Efficacy of Fascia Lata Allograft and Platelet Rich Fibrin Versus Connective Tissue Graft on the Periodontal Phenotype Around Dental Implant in Upper Anterior Region: A Randomized Controlled Clinical Trial
Phase: PHASE4
Conditions: Allograft
Sponsor: Kafrelsheikh University

 
 
 
Oral Medicine, Periodontology 
Oral Diagnosis and Oral Radiology Department 
Kafr Elsheikh University 
Faculty of Oral and Dental Medicine 
 
 
 
Efficacy of Fascia Lata Allograft and Platelet Rich Fibrin versus Connective 
Tissue Graft on the Periodontal Phenotype Around Dental Implant in Upper 
Anterior Region: A Randomized Controlled Clinical Trial 
 
 
 
 
Protocol of Thesis Submitted in Partial Fulfillment of the Requirements for Doctor 
Degree in Periodontology 
1/1/2024 
 
 

 
Introduction  
 
Nowadays, dental implants offer a reliable therapeutic option for tooth replacement 
therapy. However, along with the widespread application of dental implants, the risk of peri-
implant disease has emerged.  The new classification of peri-implant diseases and condition are 
classified the peri-implant diseases into peri‐implant health, peri‐implant mucositis, peri‐ 
implanitis, soft and hard tissue deficiencies. (1)  
Peri‐implant health is characterized by the absence of erythema, bleeding on probing, 
swelling, and suppuration. The main clinical characteristic of peri‐implant mucositis is bleeding 
on gentle probing. Erythema, swelling, and/or suppuration may also be present. Peri‐implantitis 
is a plaque‐associated pathological condition occurring in tissues around dental implants, 
characterized by inflammation in the peri‐implant mucosa and subsequent progressive loss of 
supporting bone. The evidence is equivocal regarding the effect of keratinized mucosa on the 
long‐ term health of the peri‐implant tissue. It appears, however, that keratinized mucosa may 
have advantages regarding patient comfort and ease of plaque removal. Hard‐ and soft‐tissue 
deficiencies at dental implants are common clinical findings. They can lead to complications and 
compromise implant survival and, hence, may require therapeutic interventions. (2)  
The term "periodontal phenotype" comprises two terms, gingival phenotype (gingival 
thickness and keratinized tissue width) and bone morphotype (buccal bone plate thickness). 
Periodontal phenotype can be evaluated through clinical or radiographic assessments and may be 
divided into invasive/non-invasive (for gingival thickness), static/functional (for keratinized 
tissue width), and bi/tridimensional (for buccal bone plate thickness) methods. (3) 

The connective and support tissue around the implant keeps and protects the implant as it 
is in natural teeth. (4) Unlike natural teeth, the parallel course of connective tissue fibrils around 
the implant abutment creates a weaker sulcular barrier area. So, Sufficient amount of keratinized 
gingiva around the implant protects the connective and supporting tissue by reducing the 
accumulation of plaque and creating an immobile gingival sulcus. There is a consensus about the 
positive effects of keratinized tissue width on the survival rate of dental implants. The proper 
width and thickness of the gingival connective tissue has been proven to be one of the success 
criteria in dental reconstructive surgery. (5)  
Good quality soft tissue determines the possibility not only to obtain full primary wound 
closure during the bone defect reconstruction, but also assures effective implant treatment. (6) 
Moreover, it is very important to assure the proper emergence profile of the implant supported 
restoration, which gives the opportunity to achieve the highest aesthetic appearance. (7)  
Thick, soft tissue helps to prevent the development of an inflammatory reaction and 
clinical attachment level loss (CAL), as well as alveolar bone loss. Besides, it prevents gingival 
recessions arising, which have an influence on the final aesthetics and on the likelihood of 
developing inflammatory complications. (8) They found that the initial gingival tissue thickness at 
the crest may significantly affect the marginal bone loss (MBL) around implants and when the 
soft tissue was less than 2.0 mm thick, more crestal bone loss appears. (9)  
 
Augmentation is a method to gain keratinized gingiva and various graft alternatives can 
be used in an augmentation. Augmentations with autogenous grafts are preferred due to the low 
costs and less complications however, connective tissue grafting showing some operative 
difficulties like connective tissue harvesting, the possibility of bleeding, technique sensitivity in 
addition to postoperative complications like bleeding from the donor site, pain, patient 

discomfort, and delayed wound healing. (10)  Alternative allograft materials have been developed 
to eliminate the disadvantages of autogenous grafts. (11)  
 Connective tissue graft (CTG) is the best choice for peri-implant soft tissue 
augmentation. (12) From the biological point of view, SCTG has the potential to induce the 
differentiation of mesenchymal cells into fibroblasts, which promotes epithelial proliferation and, 
consequently, helps modulate the soft tissue phenotype. (13) Nevertheless, postoperative donor-
site morbidity, bleeding, infection, necrosis, limited availability of graft tissue, and the possible 
patient’s discomfort at the second surgical site are the main drawbacks of such treatment 
modality. (14)  
 
A novel allogenic-derived acellular matrix produced from human fascia lata allograft 
(FLA) has been authorized as a viable alternative to soft tissue grafts and SCTGs in periodontal 
plastic surgery, ridge augmentation, socket grafting, as well as gingival recession and intraoral 
soft tissue abnormalities. (15) Fascia lata offers the advantage of eliminating the morbidity 
associated with human donor tissue, as well as being more widely available, affordable, and 
scalable. The antigenic cellular components are eliminated without compromising the structural 
integrity of the tissue, while leaving the extracellular collagenous matrix intact. (16)  
Platelet rich fibrin (PRF) has been introduced as an alternative to the SCTG to augment 
the gingival phenotype. It consists of a fibrin network containing platelets and a variety of 
growth factors, including transforming growth factor-beta1 (TGF-β1), platelet-derived growth 
factor (PDGF), vascular endothelial growth factor (VEGF). (12) These molecules are slowly 
released and act directly to promote the proliferation and differentiation of fibroblasts. Even 
though the efficacy of applying PRF membrane in improving peri-implant soft tissue phenotype 
has been reported, more research work is still required to investigate its clinical performance. (17) 

PRF efficacy in optimizing and preserving the existing osseous structure and gingival 
architecture across peri-implant need to be corroborated.  Shetty et al. in their study 
demonstrated that the placement of PRF membrane over denuded root surface in conjunction 
with coronally advanced flap results in the improvement in the thickness of gingiva. (18)  In the 
long-term, the correct width and thickness of the attached keratinized tissue is the key point to 
ensure the stable position of the gumline around the implant’s neck. (19) Therefore, the aim of this 
study was to improve periodontal phenotype surrounding the dental implants placed in patients 
to prevent any possible future complications which may occur. 
 
Aim of the study 
To compare between the efficacy of fascia lata allograft and platelet rich fibrin versus 
subepithelial connective tissue graft on periodontal phenotype (thickness and width of 
keratinized tissue, labial bone thickness) around dental implant in upper anterior region. 
 
Materials and Methods 
Study Design: 
The present study will be conducted as a randomized controlled clinical study,  
Study setting: 
The study will be conducted in the clinic of Oral Medicine, Periodontology, Oral Diagnosis and 
Oral Radiology Department, Faculty of Dentistry, Kafer El sheikh University. 
Ethical approval: 
Before the treatment, the purpose of the study and the surgical procedures will be 

explained to the patients who will be selected to participate in the study and an informed consent 
will be obtained from all patients before the beginning of any dental treatment by presenting the 
available three treatment options which were used in this study, representing the possible 
complications which may occur due to the presence of thin gingival biotype at the site of future 
implant placement, and the possible post-surgical complications which may occur after implants 
placement such as possible pain, post-operative bruising and extra-oral swelling.  
Participation in the study is voluntary and stated the possibility to withdraw at any time. 
An official permission to conduct the study will be obtained from the Research Ethics 
Committee (REC), Faculty of Dentistry, Kafer El sheikh University. The research will be 
conducted in compliance with the 2004 revision of the Declaration of Helsinki. Confidentiality 
of the information where it will not be accessed by any other part without taking permission of 
the participants.  
Sample size calculation: 
 
Totally 24 patients. Allocated equally into three groups, 8 patients treated with sub-
epithelial connective tissue graft (SCTG), another 8 patients treated with platelet-rich fibrin 
(PRF)graft, and another 8 patients treated with Fascia Lata Allograft. 
Sample size was calculated using the G*power, version 3.1.9.2, Universität Kiel, 
Germany based on comparing the pink esthetic score six months after implant placement (T1) 
among patients treated with SCTG and PRF (Elkashty, A.A., et al.,2022)  
Mean ± SD of T1 among patients treated with SCTG = 5.1 ± 0.99  
Mean ± SD of T1 among patients treated with PRF = 3.5 ± 1.1  
 error probability = 0.05 
Power (1- error probability) = 0.80 

So, the sample size for each group will be 8 patients.  
 
 
Site selection: 
Twenty-four patients diagnosed with missing upper anterior due to factors other than 
periodontally involvement based on clinical and radiographically examination and fulfill the 
following eligibility criteria: 
Inclusion criteria: 
1. Patients age ranged from 20 to 50 of both genders. 
2. Patients are systemically medically free according to the American Society of 
Anesthesiologists (ASA) considered as ASA I. (20) 
3. Patients with thin gingival biotype (gingival thickness was ≤1 mm) 
4. The height of keratinized gingiva (HKG) for the site selected should be ≥2 mm. 
5. Ability to maintain good oral hygiene as evidenced in recall visits. 
6. Sufficient mesiodistal and interocclusal space and have an intact facial bone wall which 
does not require bone augmentation procedures. 
7. Adequate bone quality. 
8. Ability to maintain good oral hygiene as evidenced in recall visits. 
Exclusion criteria: 
1. Smoker patient and pregnant or lactating woman. 
2. Patient with poor oral hygiene or active periodontal disease. 
3. Traumatic occlusion or para-functional habits such as clenching or bruxism. 
4. Patient with limited mouth opening. 

5. Participation in other clinical trials  
 
 
Materials:  
1) Implant system* Dual implant  
2) Fasia lata allograft from Maxxeus company 
3) PRF will be prepared according to Choukroun et al. (21)  
4) CTG will be taken according to Langer & Langer (22)   
Study design: 
1) Patients group: 
Patients were classified into three main groups: 
- 
Group 1 (Study group) 
It includes eight patients seeking for implant placement in the upper anterior areas and 
implants will be placed with the application of fascia lata allograft membrane. 
- 
Group 2 (Study group) 
It includes eight patients seeking for implant placement in the upper anterior area and 
implants will be placed with the application of PRF. 
- 
Group 3 (Control group) 
It includes eight patients seeking for single implant placement at the upper anterior area 
and those patients will be received their implants with subepithelial connective tissue 
graft. 
2) Pretreatment preparation before surgery: 
All the patients participate in this study regarding the patient’s groups will undergo: 

1. History taking, examination and preoperative laboratory investigation (bleeding tendency 
tests, HIV, HBV and HCV) to confirm suitability to the eligibility criteria. 
2. A cone beam computed tomography (CBCT) will be taken to confirm the diagnosis and 
evaluate bone level and bone density. 
3. Occlusal adjustment will be done in cases with clinical and radiographic evidenced 
trauma of occlusion. 
3) Phase I therapy: 
All the patients will undergo comprehensive phase I therapy and re-evaluation will be done 
after 4 weeks to evaluate the patient response to phase I therapy. 
4) Surgical phase: 
 Implant placement: 
1- Group 1: (Dental implant + Fasia lata)  
Preparation of the alveolus for delayed dental implant placement will be done according to 
manufacturer instructions and fasia lata will be fixed around dental implant.  
2- Group 2: (Dental implant + PRF)  
Preparation of the alveolus for delayed dental implant placement will be done according to 
manufacturer instructions and PRF will be fixed around dental implant.   
3- Group 3: (Dental implant + CTG)  
Preparation of the alveolus for delayed dental implant placement will be done according to 
manufacturer instructions and CTG will be fixed around dental implant.  
5) Postoperative care: 
All patients will receive post-operative instructions including, rinsing with 0.2% chlorhexidine 
(twice daily for 2weeks), For postsurgical pain control, 600 mg ibuprofen every 4 to 6 hours was 

prescribed, and 500 mg amoxicillin was prescribed 3 times daily for 7 days to prevent infection. 
The patient was instructed to avoid brushing and trauma to the surgical site. 
 
 
6) Prosthetic phase: 
The final implant impression restoration will be made after 6 months from the surgery and 
fabrication of the abutment.  
Clinical assessment: 
The patients will be recalled at two weeks, month, 3 months, and 6 months   post-surgery to 
record the clinical parameter which will be recorded by the same doctor. 
A. The following clinical parameters will be recorded: 
1- Pink aesthetic score (PES) (23) (Table 1) 
Parameter 
0 
1 
2 
Mesial papilla 
Missing 
Incomplete 
Complete 
Distal papilla 
Missing 
Incomplete 
Complete 
Tissue contour 
Unnatural 
Virtually natural 
Natural 
Gingival level 
>2mm 
1-2 mm 
1 mm 
Alveolar process 
Clearly resorbed 
Slight resorbed 
No difference 
Coloring 
Clear difference 
Slight difference 
No difference 
Texture 
Clear difference 
Slight difference 
No difference 
 
2- Wound healing index (WHI): will be recorded at 7,14 days 1 and 3months according to 

Huang et al.  (24) 
3- Gingival thickness (GT) will be measured at the mid-buccal 2 mm apical to the free 
gingival margin (at baseline, 3 months, and 6 months post-surgery) by penetrating a probe 
into the tissue. (24) 
4- Peri-Implant Periodontal Probing depth (PPD): 
 
This index depends mainly on the usage of 0.5 mm Michigan O probe with graduations. 
Measurements were evaluated at six sites per each implant i.e., the distofacial surface, mid facial 
surface, mesiofacial surface, mesio-lingual surface, mid lingual surface, and disto-lingual 
surfaces of the implant. PPD was measured by taking the reading from the free gingival margin 
to the base of the pocket. The mean score of the implant was obtained by adding the six scores 
and dividing it by six. (29) Measurements were recorded to the nearest 0.5 mm six months after 
implant placement (prosthetic phase) (T1) and three months after the prosthesis placement. 
Radiographic Evaluation: 
Marginal (crestal) bone loss (MBL): 
Radiographic examination of the patients will be done firstly pre-operative then just after the 
surgical procedures as a base point and at six months follow-up period post-operative by using 
CBCT (Morita) device. On Demand3D program was used for image reconstruction and analysis. 
For the calculation of marginal (crestal) bone loss (MBL), the implant was used as a reference by 
adjusting the cross-sectional long axis in the center of the implant and bisecting it. A line was 
drawn parallel to the implant, starting at the crest of the bony cortical plate of bone and ending at 
the apical level of the implant; height was recorded in millimeters immediately, 6 months 
postoperative.  The same process was repeated from the palatal direction. 
Statistical analysis: 

The data will be collected and tabulated where statistical analysis will be done using 
statistical package for social science software (SPSS version 20) and comparison between the 
studied groups will be performed.  
 
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