The Use of Coronally Advanced Flap and Subepithelial Connective Tissue Graft With or Without Platelet Rich Fibrin in the Treatment of Miller Class I or II Gingival Recession: a Randomized Clinical Trial
Phase: NA
Conditions: Gingival Recession
Sponsor: Cairo University

Protocol 
The use of coronally advanced flap and subepithelial connective 
tissue graft with or without platelet rich fibrin in the treatment 
of Miller class I or II gingival recession: a randomized clinical trial 
ا ستخذام
سذيلة هتقذهة كورونالي و  تطعين باالنسيح 
 الضام هع أو بذون الصفائح
 الذهوية الغنية الليفين في عالج هيلر األول أو الثاني الركود اللثوي: تجربة
سريرية عشوائية 
 
Protocol 
Submitted to the Faculty of Oral and Dental Medicine-Cairo University in partial 
fulfillment of requirements for Doctorate Degree in Periodontology  
BY 
Sarah Mohamed Ehab Elbanna 
B.Sc(2007) Oral Medicine and Periodontology Department 
Cairo University 
1. Title: 
The use of coronally advanced flap and subepithelial connective tissue graft with or 
without platelet rich fibrin in the treatment of Miller class I or II gingival recession: a 
randomized clinical trial. 
2. Trial registration: 
NCT03199118 
3.Protocol version 
Protocol no 1., revised and approved by the Ethics Committee of Scientific Research -
Faculty of Oral and Dental Medicine– Cairo University in 30/09/2017. 
 
4. Funding: 
Self-funding. 
 
 
 

5. Roles and responsibilities: 
Supervisors and principle investigator: 
Main supervisor 
Prof.Azza Ezzelarab 
-Cairo University. 
Role: 
- 
Initiation and idea of the clinical trial. 
- 
Randomization, sequence generation and allocation concealment of cases. 
- 
Data monitoring 
-supervisor 
Prof. Noha Ayman Ghallab 
  Professor of Oral Medicine and Periodontology- Cairo University. 
Role:  
- 
Initiation and idea of the clinical trial. 
- 
Measuring and recording the outcomes of the study: Recession width, recession 
depth, % of root coverage, probing depth, clinical attachment level, keratinized 
tissue biotype, root coverage esthetic score (RES), post-operative pain.  
- 
Data collection  
ator 
Sarah Mohamed Ehab Elbanna 
  Assistant lecturer in Oral Medicine and Periodontology department– Cairo University. 
- 
Role: 
- 
Surgical treatment. 
M. Amira Mohamed 
 Responsible for filing system in Oral Medicine and Periodontology department– Cairo 
University. 
- 
Role: 
- 
Data management  
 

 D. Role of steering committee 
o Department of Oral Medicine and Periodontology, Faculty of Oral and Dental 
Medicine - Cairo University. 
It is responsible for ensuring that the research idea follows the research plan of 
the department . 
o Evidence Based Committee, Faculty of Oral and Dental Medicine - Cairo 
University. 
It is responsible for: 
 
 Pico revision. 
 
Protocol revision. 
 
Reporting the methodology. 
 
Sample size calculation and reporting of statistical methods. 
o Ethical Committee, Faculty of Oral and Dental Medicine - Cairo University 
It is responsible for: 
 Ensuring that the trial does not violate privacy, ethical issues, or human rights. 
 Supplying the main investigator with a template of informed consent. 
 Approving the research, once it fulfills the required ethical criteria. 
o Faculty and University board 
It approves the protocol once it is approved by the previously mentioned boards and 
committees. 
 
 
 

Introduction 
6. Background and rationale 
Gingival recession is a frequent, unwanted apical shift of the marginal tissue 
beyond the cemento-enamel junction (CEJ) and may cause faulty dimensions of 
keratinized tissue and aesthetic problems. The high concern in aesthetics and the resulting 
need to solve related problems such as hypersensitivity and root caries have preferred the 
advancement of many surgical plan that permit the coverage of exposed roots (Roccuzzo 
et al., 2002). 
- 
Statement of the problem: 
Gingival recession (GR) is a typical appearance in many populaces, and is 
considered as an early indication of periodontal sickness. A review showed that gingival 
subsidence is a typical condition with a pervasiveness of 68% for males contrasted with 
females who had 32% gingival recession (Manchala et al.2012).  
- 
Rationale for carrying out the trial:  
Subepithelial connective tissue graft (SCTG) secured by a coronally advanced flap (CAF) 
is one of the substantial surgical alternatives and is utilized as often as possible because 
of its great consistency (Wennstrom and Zucchelli, 1996; Paolantonio et al., 2002; 
Tozum and Demiralp, 2003). However, uncertain complete root coverage (between 18.1 
%and 86.7%) has been documented as well as confined regeneration of the lost 
attachment apparatus with a remedial through long junctional epithelium or adaptation of 
connective tissue to the root surface after the use of CAF+SCTG (Cummings et al. 
2005).  
 One of the enhancers of periodontal tissue regeneration and promoters of early 
wound healing is found to be the Platelet rich fibrin (PRF)  (Tozüm et al. 2003). There 
are only a few reports documenting the use of platelet rich plasma (PRP) in aesthetic 
periodontal surgery.  Petrungaro (2001) published a case series in which PRP, SCTG 
and collagen membranes were used to cover gingival defect. The 2 months study resulted 

in 3 mm root coverage. Accordingly, this study will assess the effect of PRF as an adjunct 
to CAF+SCTG on root coverage outcomes. 
Introduction and review of literature 
Gingival recession [GR] has been characterized as an apical move of the gingival 
edge over the CEJ and the unmasking of the root surface to the oral condition. (Kassab et 
al.2003). It is a familiar and unwanted condition that is commonly seen in dental clinics 
and affects population of all ages across the planet, represents the status of periodontal 
tissue and that‟s why it is not seen as a disease itself. Its existence is annoying for patients 
due to esthetic, mental and functionnal issues, e.g. dentine hypersensitivity, root caries 
and abrasion, cervical wear, tooth movement and dental erosion because of the exposure 
of the root surface to the oral environment (Tugnait et al.2001). Armittage (1999) has 
described forms of GR in the absence of periodontal disease which are known as 
developmental or acquired deformities and conditions. 
The etiology of GR is multifactorial and is dependably the aftereffect of more 
than one component acting together, for example, anatomical [alveolar bone dehiscence, 
high muscle connection, occlusal injury, frenal pull, thin gingival biotype], inflammatory 
[destructive periodontal disorder, nearness of dental plaque and supra/subgingival 
calculus, inadequate teeth brushing], traumatic variables [vigorous oral cleanliness 
routine, oral piercing] and iatrogenic elements identified with reconstructive, 
conservative, orthodontic, periodontologic or prosthetic treatment (Tugnait et al.2001; 
Kassab et al.2003;  Dilsiz et al.2010). 
Normal periodontal tissue can be affected by GR (Tugnait et al.2001) and looks 
like a wedge shaped lesions on the buccal surface of the teeth, notably associated with 
malposed teeth and hard toothbrush use (Khocht et al.1993), while in persons with bad 
oral hygiene it can be seen on any tooth surface (Loe et al.1992). In majority of cases, 
root coverage methods not just aims to completely cover the denuded root and to enhance 
esthetics, but also to increase the width of the gingival tissue covering the recessions to 
enhance long term stability. (Kennedy et al.1985). 

 Free gingival grafts, grafts bringing together two modalities, pedicle grafts and 
guided tissue regeneration are among several treatment options for covering the exposed 
roots and to increase the width and thickness of the keratinized gingiva (Bruno, 1994). 
Better esthetics, ease of plaque control and reduction of hypersensitivity are the main 
outcomes of these procedures. (Michaelides and Wilson, 1994).  
CAF brought about the re-development of epithelial and connective tissue 
attachment with insignificant bone repair. Thereafter, many additionnal agents have been 
applied to improve healing and additionnaly reinforce clinical result. These include 
guided tissue regeneration (GTR) Bio-resorbable membrane (Zucchelli et al., 1998), 
enamel matrix proteins   SCTG (Berlucchi et al., 2002) recombinant growth factors, PRP 
and PRF (Gonshor, 2002).One of the highly predictable surgical options is the CTG 
covered by a CAF (Wennstrom and Zucchelli, 1996; Paolantonio et al., 2002; Tozum 
and Demiralp, 2003). However, inconsistent complete root coverage (between 18.1 
%and 86.7%) and limited regeneration of the missing attachment apparatus with a 
healing through long junctional epithelium or adaptation of connective tissue to the root 
surface after the use of CAF+SCTG ( Cummings et al.2005). 
According to Marx et al. (1998) who first reported applications and clinical 
benefits of PRP, it is “a volume of autologous plasma that has a platelet concentration 
above the baseline”. Due to its good effect on wound healing acceleration, PRP has 
become a target of lots of researches. It is derived from concentrated platelets, allowing it 
to deliver a greater concentration of autologous growth factors including platelet derived 
growth factor, transforming growth factor-β, vascular endothelial growth factor, epithelial 
growth factors, insulin like growth factor. (Okuda et al., 2003). 
The use of PRF, a second-generation platelet concentrate, gives more advantages 
than the PRP. The main difference between PRF and commercially available PRP 
systems is that PRF does not need bovine thrombin or other exogenous activators in the 
preparation process. A gel-like substance is obtained after PRF preparation, containing 
high concentrations of non-activated, functional, intact platelets, contained within a fibrin 
matrix, that release, a relatively constant concentration of growth factors over a period of 
7 days. Also a membrane can be produced by squeezing the gel-like matrix that can be 

used as fibrin bandage acting as a matrix to fasten the healing of wound edges. Moreover 
its preparation is relatively easy, simple and fast. An economical autologous membrane is 
obtained in nearly 1 min and therefore the cost of a membrane and bone graft is avoided 
(Thorat et al. 2011) . Homeostasis and wound healing are stimulated by PRF and it has a 
supportive effect on the immune system, cell migration, and proliferation (Dohan et 
al.2006) 
Numerous clinical and histological studies reveal that a specific platelet-
concentrated therapeutic concept could be an encouraging medium for the enhancement 
of soft tissue healing and regeneration in periodontology and implantology (Pini-Prato et 
al., 1999). Promising results have been recorded with the use of PRF in several 
periodontal surgical techniques, and healing of intrabony and furcation defects (Sharma 
et al.2011). It may be thought that PRF can have a positive effect on the treatment 
outcomes of root coverage technique. 
-Aim of the study 
The aim of this randomized controlled clinical trial with a 6 months follow-up is to 
evaluate the effectiveness of CAF+SCTG+PRF in the treatment of Miller class I and II 
recession defects and to compare the outcomes to CAF+SCTG alone. 
-PICOTS elements: 
P (Patient/ Population): Patients with Miller‟s class I or II gingival recession. 
I (Intervention): root coverage using CAF with SCTG and PRF. 
C (Comparator /Control): root coverage using CAF with SCTG alone. 
O (Outcome): recession depth 
T: 6 months follow-up 
S (Study design): Randomized controlled clinical Trial 
 

 
Research question: 
In patients with Miller class I or II gingival recession, does the use platelet rich fibrin in 
conjunction with CAF and SCTG reduce the recession depth if compared to CAF and 
SCTG alone?  
7. Objectives of the study: 
This research will be conducted in an attempt to achieve complete root coverage with 
physiologic probing depth and a harmonious view with the adjacent tissues using PRF in 
conjunction with CAF and SCTG. 
 Research hypothesis: 
Null hypothesis: In patients with Miller class I and II gingival recession, there is no 
difference in root coverage outcomes following placement of PRF in conjunction with 
CAF and SCTG compared to CAF and SCTG alone. 
 
 The primary objective: 
Recession depth which will be measured before the surgical procedure, then after 3 and 6 
months. 
 
 The secondary objectives: 
 
Outcome name 
Measuring Device 
Measuring 
Unit 
Primary1ry 
Recession depth 
William‟s graduated Periodontal 
probe 
mm 
Secondry2ry Recession width 
William‟s graduated Periodontal 
probe 
mm 
Root coverage gain 
William‟s graduated Periodontal 
probe 
mm 
Probing depth 
William‟s graduated Periodontal mm 

probe 
Clinical attachment 
level 
William‟s graduated Periodontal 
probe 
mm 
Gingival biotype 
William‟s graduated Periodontal 
probe 
mm 
Width of keratinized 
gingiva 
William‟s graduated Periodontal 
probe 
mm 
Patient satisfaction 
 
Printed questionnaire 
Binary (Zuhr et al.2014) 
Yes/No 
Root 
coverage 
esthetic score 
Score 
(Cairo et al. 2009) 
Categorical 
 
Post-Operative Pain  
Numerical Rating Scale (NRS) 
(Breivik et al. 2008) 
Numerical 
 
 
8. Trial design: 
 
 
Methods 
9.Study setting: 
department, Faculty 
of Oral and Dental Medicine – Cairo University, Egypt. 
 
Medicine and Periodontology-Cairo University: 
- 
Dental units: Adec / knight 
- 
Operator:  PhD degree student in periodontology department 
- 
Assistant: present 
 
10.Eligibility criteria 

i) Inclusion criteria: Patients eligible for the trial must comply with all of the following: 
1) Patients 18 years and older 
2) Buccal recession defects classified as either Miller class I or II gingival recession. 
3) Clinical indication and/or patient request for recession coverage 
4) Good oral hygiene 
 
ii) Exclusion Criteria 
1) Miller Class III and IV gingival recession.  
2) Any systemic diseases or any medication. 
3) Pregnancy. 
4) Patients undergoing radiotherapy. 
5) Handicapped and mentally retarded patients. 
6) Current and former smokers as smoking is a contra-indication for plastic 
periodontal surgery (Khuller 2009). 
7) Teeth with cervical restorations, abrasion. 
11. Intervention: 
11a- General operative procedures: 
Preoperative evaluation 
A periapical radiograph using paralleling technique will be performed for each patient. 
The patients will be randomly assigned into two groups; 
Group A: patients receiving CAF with SCTG alone. 
Group B: patients receiving PRF+CAF+SCTG. 
Clinical examination: 
Each patient will be examined intra-orally to check the conformity of the patient to the 
eligibility criteria mentioned before. If the patient meets the criteria, phase I therapy for 

periodontal plastic procedures will be performed including thorough supragingival 
scaling and subgingival debridement. Maintenance of proper plaque control (both 
mechanical and chemical) by the patient will be also implemented. 
Surgical procedures: 
SCTG harvesting: 
A measurement of the approximate length and width of the graft required will be 
taken. The graft will be harvested from the palate between the distal aspect of the canine 
and the midpalatal region of the first molar.  Two parallel incisions will be performed in 
the palate using blade n.15, staying at least 2 mm away from the tooth margin. Pressure 
will be applied to the donor site with gauze soaked in saline after the graft will be taken. 
Silk sutures are used to simultaneously approximate both the flap margins and the 
entirely undermined donor area. 
 
Surgical protocol: 
The surgical area will be prepared and adequately anesthetized using 2% 
lignocaine HCL containing 1:80,000 epinephrine by giving block and infiltration 
anesthesia. After obtaining adequate anesthesia, two vertically divergent incisions (i.e. 
one mesial and one distal, immediately adjacent to the defect) extending beyond the MGJ 
will be made on the buccal aspect of the involved tooth. The sulcular incision will then be 
placed up to the end of the vertical incisions. Care will be taken to see that the papilla is 
intact. A trapezoidal flap will be elevated by a sharp dissection with no. 15 scalpel blade 
to raise a combined full-partial thickness flap to the level of the MGJ. 
The flap will be extended well beyond the mucogingival junction so that it 
exhibits no tension when pulled coronally beyond the CEJ and should be extended at 
least 5 mm coronal to the most apical margin of the bony dehiscence. The intact papillae 
mesial and distal to the recession will be de-epithelized to provide a bleeding connective 
tissue bed for future the SCTG. 
In the test group (group A), the root surface will be covered with the PRF 
membrane exceeding the margins of surrounding alveolar bone before placing SCTG, 
while in the control group (group B), SCTG will be placed over the recession defect 

leaving the coronal margin of the graft at the level of the CEJ. In both groups, all graft 
material will be sutured to the periosteum using 5-0 resorbable suture. Finally the flaps 
will be positioned coronally to the CEJ without tension using 5-0 silk suture. Hemostasis 
will be achieved by applying gentle finger pressure for 4 minutes. 
PRF preparation: 
This procedure will be done only if the patient is allocated to group A where PRF will be 
placed and after the flap in the recession site has been prepared. Just before SCTG 
harvesting, blood will be taken from the anticubital region with a 24-gauge needle and 
injected into the 10-mL glass coated collection tube without anti-coagulant then 
immediately centrifuged at 2700 rpm for 12 minutes with a table centrifuge. The fibrin 
clot will be collected from the middle part of the tube and packed tightly in 2 sterile 
saline impregnated gauze in order to obtain a fibrin membrane. 
 
A post-surgery protocol will be implemented emphasizing wound stability and 
infection control, including 0.12% chlorhexidine rinse twice per day. Gingival sutures 
will be removed 2 weeks post-surgery. Mechanical plaque control in the surgical area 
will be reinstituted at week 8 following surgery. Patients will be recalled for 
supragingival scaling and oral hygiene instructions on a monthly basis for the 6-month 
observation interval. 
 
11.b: Criteria for Discontinuing or Modifying Intervention: 
al if any harm occurs to the patient. 
recession or 
periodontal abscess. 
11-c: Strategies to improve adherence to intervention: 
The patient will be followed up weekly the first month. The operator should explain the 
importance of follow up. Adherence to oral hygiene measures will be verified by showing 
the patient the amount of plaque on the periodontal probe and bleeding on probing using 
a mirror. The patient will receive 2 phone calls to remind him the follow up visit. Phone 

number of a close person will be collected in case we cannot reach him on his phone. If 
the patient does not show up a home visit might be considered. 
11-d: Concomitant care 
The patients will receive postoperative instructions and oral hygiene guidelines that 
should be followed during the 6 month follow-up period. Patients will be recalled every 1 
week for first month and then every month for supportive periodontal therapy till 6 
months follow up. 
Medications: Chlorohexidine 0.12% mouthwash 2 times/day for 1 week 
                    Brofen 400 mg 3 times/day for 5 days 
                    Soft tooth brush is to be used 
 12- Outcomes:  
Dr Noha is responsible for measuring all the outcomes and collecting data.  
 
Outcome name 
Measuring Device 
Measuring 
Unit 
Primary1ry 
Recession depth 
William‟s graduated Periodontal 
probe 
Mm 
Secondry2ry Recession width 
William‟s graduated Periodontal 
probe 
Mm 
Root coverage gain 
William‟s graduated Periodontal 
probe 
Mm 
Probing depth 
William‟s graduated Periodontal 
probe 
Mm 
Clinical attachment 
level 
William‟s graduated Periodontal 
probe 
Mm 
Gingival biotype 
William‟s graduated Periodontal 
probe 
Mm 
Width of keratinized 
gingiva 
William‟s graduated Periodontal 
probe 
Mm 
Patient satisfaction 
 
Printed questionnaire 
Binary (Zuhr et al.2014) 
Yes/No 
Root 
coverage Score 
Categorical 

esthetic score 
(Cairo et al. 2009) 
 
Post-Operative Pain  
Numerical Rating Scale (NRS) 
(Breivik et al. 2008) 
Numerical 
The probe is held parallel to the long axis of the tooth. The pressure applied with the 
probe tip should be between 10-20 grams. Blanching of the gingiva should be avoided. 
 Recession depth: from the CEJ to the margin of the gingiva at the midbuccal point 
of the teeth. 
 Recession width: measured horizontally between two borders of the recession 
 % of root coverage: (preoperative vertical recession – postoperative vertical 
recession/preoperative vertical recession) x 100. 
 Probing depth: measured from the gingival margin to the base of the pocket probe 
at the midbuccal point of the teeth. 
 Clinical attachment loss: measured from the CEJ to the base of the sulcus at the 
midbuccal point of the teeth. 
 Gingival biotype: under local anesthesia from 3 mm below the gingival margin 
trans-gingivally piercing tissues horizontally, perpendicular to the long axis of the 
tooth until it contacts bone. 
 Width of keratinized gingiva: from the margin of the gingiva to the mucogingival 
junction at the midbuccal point of the teeth. 
 Patient satisfaction: printed yes/ no questionnaire with 3 questions 
 Root coverage esthetic score (Cairo et al. 2009) 
 Post-Operative Pain: Numerical Rating Scale (NRS) with numbers from 0 to 10 
(„no pain‟ to „worstpain imaginable‟) for the first 2 weeks postoperatively. 
(Breivik et al. 2008)   
     
13. Participant timeline 
instructions and will be motivated to stick to these instructions. 
 receiving the treatment, patients will be followed-up for 6 months. 
 
 

 
Time point 
T0 
T1 
T2 
T3(weekly 
till T4) 
T4(1 
month) 
T5 (3 
months 
T6(6 
months) 
Enrollment 
X 
 
 
 
 
 
 
Eligibility 
screening 
X 
 
 
 
 
 
 
Informed 
consent 
X 
 
 
 
 
 
 
Initial phase 
(oral hygiene) 
 
X 
 
 
 
 
 
Allocation 
 
 
X 
 
 
 
 
Intervention 
 
 
X 
 
 
 
 
Post-operative 
care 
 
 
 
X 
X 
 
 
 
 
Assessment 
Radiograph 
X 
 
 
x 
X 
X 
X 
Recession 
depth 
 
X 
 
 
 
X 
X 
%of root 
coverage 
 
 
 
 
 
 
X 
Probing depth 
 
X 
 
 
 
X 
X 
Clinical 
attachment 
level 
 
X 
 
 
 
X 
X 
Gingival 
biotype 
 
X 
 
 
 
X 
X 
RES 
 
 
 
 
 
 
X 
Questionnaire 
 
 
 
 
X 
 
 
Post-operative 
pain 
 
 
 
X 
 
 
 
 

 
 14 - Sample size 
The aim of this study is to evaluate the use of coronally advanced flap and subepithelial 
connective tissue graft with or without platelet rich fibrin regarding Recession depth.  In 
a previous study by Keceli et al., 2015 the expected difference in Recession depth 
decrease from baseline between 2 groups is 0.45±0.38mm. Using power 80% and 5% 
significance level we will need to study 12 in each group to be able to reject the null 
hypothesis that the population means of the experimental and control groups are equal. 
This number is to be increased to 14 in each group to correct for non-parametric usage 
and increased again to 17 to compensate for possible losses during follow up. Sample  
size  calculation  was achieved  using  PS:  Power  and  Sample  Size  Calculation  
software  Version  3.1.2  (Vanderbilt University, Nashville, Tennessee, USA ). 
 
15- Recruitment strategy: 
from the outpatient clinic of the Oral Medicine and 
Periodontology department, Faculty of Oral and Dental Medicine-Cairo University  
 (Consecutive 
sampling) 
ing potential subjects will be achieved through patient database. 
 
16-Allocation 
Patients will be randomly allocated using computer generated randomization 
(www.randomizer.org) and will be performed by Dr Azza.  The numbers will be 
allocated to each patient. 
 
16a-Allocation concealement mechanism 
 two groups will be treated will be equally prepared for surgical procedure. Then 
the decision of which group will receive CAF+SCTG and which will receive 
CAF+SCTG combined with PRF will be selected according to the randomized numbers 
placed in opaque sealed envelopes. The number will be picked by participant. 
 

16b-Implementation: 
will be randomized. 
Dr Azza who is neither involved in the treatment 
nor in the outcome measuements. 
 
17-Blinding 
- 
Blinding of the participants and operator is not applicable because of the nature of 
the treatment. 
- 
Outcome assessor will be blinded. 
- 
The biostatistician will be blinded. 
 
18-Data collection methods 
18a-Data collection method: 
The phone numbers and address of the patient included in the study will be recorded from 
them or extracted from the patient‟s file which will be available at Ms. Amira‟ s office , 
the one responsible for filing system in the Oral Medicine and Periodontology department 
The data will be collected by dr Noha, whether personal or numerical. They will be 
stored on excel sheets as an electronic copy and printed hardcopy sheets. The outcome 
data will be collected at 0, 3 and 6 months. Numerical data will be presented as mean and 
standard deviation 
18b- Plans to promote participant retention and complete follow- up 
ed in the study will be recorded as a part of 
the written consent. 
-determined follow up 
dates.and transportation fees may be offered. 
 
19- Data management 
 electronically by Ms Amira All paper sheets that are 
concerned with the personal or outcome data will be stored in locked cabinet and in 
the computer at the Oral Medicine and Periodontology department.  

The excel sheets of the patients data will be stored in the computer of the Oral Medicine 
and Periodontology Department- Faculty of Oral and Dental Medicine 
encrypted using a password. 
 in storage for 1 year after completion of the study. 
 
20- Statistical method:  
Data management and statistical analysis will be performed using Statistical Package for 
Social Sciences (SPSS) vs. 21.  Numerical data will be summarized using means and 
standard deviations or medians and ranges. Data will be explored for normality using 
Kolmogrov-Smirnov test and Shapiro-Wilk test. Categorical data will be summarized as 
percentages.   Comparisons between two groups and over time will be done by 2 way 
analysis of variance for repeated measures. If the time factor is not considerable, 
comparisons between the two groups for normally distributed numeric variables will be 
done using the Student‟s t-test while for non-normally distributed numeric variables will 
be done by Mann-Whitney test. A p-value less than or equal to 0.05 will be considered 
statistically significant. All tests will be two tailed. 
 
21-Data monitoring 
-No formal data monitoring committee will be needed since it is a study with known 
minimal risks. 
 
22-Harms 
Any temporary or permanent adverse effect will be recorded and documented. 
No Harms are expected.  
 
23-Auditing 
No auditing is to be done since no harms are expected. 
 
24-Research ethics approval 

-This protocol and the template informed consent form will be reviewed by the Ethics 
Committee of Scientific Research -Faculty of Oral and Dental Medicine– Cairo 
University 
 
 
25-Protocol amendments 
Any modifications to the protocol which may have an impact on the conduct of the study, 
potential benefit of the patient or may affect patient safety, including changes of study 
objectives, study design, sample sizes, study procedures, or significant administrative 
aspects will require a formal amendment to the protocol. Such amendment will be agreed 
upon by the Council of Periodontology Department. 
 
26-Consent: 
Researcher will introduce the trial to patients and provide full explanation of its 
aim and benefits in plain language.  Patients will then be able to have an informed 
discussion with the researcher.  Researcher will obtain written consent from patients 
willing to participate in the trial. All consent forms will be translated into Arabic. 
 
27-Confidentiality 
All study-related information will be stored securely. All participant information 
will be stored in locked file cabinets in areas with limited access. All reports, data 
collection, process, and administrative forms will be identified by a coded ID 
[identification] number only to maintain participant confidentiality. All records that 
contain names or other personal identifiers will be stored separately from study records 
identified by code number. All local databases will be secured with password-protected 
access systems. 
 
28- Declaration of interests 
If there will be any conflict of interest it will be declared. 
 
29-Access to data 

The principal investigator and the supervisors will be given access to the data sets. 
All data sets will be password protected. To ensure confidentiality, data dispersed to 
project team members will be blinded of any identifying participant information. 
 
 
30-Ancillary and Post Trial Care 
All patients will be followed up for one year after the clinical trial is over. 
 
31-Dissemination policy 
- Study results will be published as partial fulfillment of the requirements for Doctorate 
degree in Periodontology. 
- Topics suggested for presentation or publication will be circulated to the authors. 
 
 
 
 
 
 
 
 
 
 
(Keceli et al., 2015)Appendix: 
 
1. Pain Scale 
Filled in by the patient after being given instructions about charting by the dental 
operator. 
 

 
 
 
 
2. Post-Surgical Patient Satisfaction Questionnaire (PSPSQ): 
Filled in by the patient  
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

3. Root coverage esthetic score 
The RES system evaluates five variables 6 months following surgery: gingival margin 
(GM), marginal tissue contour (MTC), soft tissue texture (STT), mucogingival junction 
(MGJ) alignment, and gingival color (GC). The clinical esthetic evaluation is performed 
without magnification. Zero, 3, or 6 points are used for the evaluation of the position of 
the gingival margin, whereas a score of 0 or 1 point is used for each of the other variables 
- 
GM:  -Zero points = failure of root coverage (gingival margin apical or equal to 
the baseline recession) 
                        -3 points = partial root coverage;  
                         -6 points = CRC.  
- 
MTC: -Zero points = irregular gingival margin (does not follow the CEJ). 
          -1point =proper marginal contour/ scalloped gingival margin (follows the 
CEJ).  
- 
STT: - Zero points = scar formation and/or keloidlike  appearance . 
                -1 point = absence of scar or keloid formation.  
- 
MGJ: - Zero points = MGJ not aligned with the MGJ of adjacent teeth. 
          - 1 point = MGJ aligned with the MGJ of adjacent teeth. 
- 
GC:  -Zero points = color of tissue varies from gingival color at adjacent teeth.  
          -1 point = normal color and integration with the adjacent soft tissues.  
Thus, the ideal esthetic score is 10.  
Zero points are assigned if the final position of the gingival margin is equal or apical to 
the previous recession depth (failure of root coverage procedure), irrespective of color, 
the presence of a scar, MTC, or MGJ. Zero points are also assigned when a partial or total 
loss of interproximal papilla (black triangle) occurred following the treatment. 
 
 
 
 
 
 
 
 

References 
 
Berlucchi, I., Francetti, L., Del Fabbro, M., Testori, T. and Weinstein, R. L. (2002) 'Enamel matrix 
proteins (Emdogain) in combination with coronally advanced flap or subepithelial connective 
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 (Petrungaro, 2001)