Soft Tissue Augmentation by Xenogenic Collagen Matrix Versus Sub Epithelial Connective Tissue Graft Around Early Implant Placement in Maxillary Esthetic Zone
Phase: NA
Conditions: Alveolar Bone Loss, Gingival Recession, Peri-implant Mucositis
Sponsor: Minia University

Soft Tissue Augmentation by Xenogeneic Collagen Matrix Versus Subepithelial Connective Tissue Gra
Document Type: Study Protocol
NCT Number: (To be assigned)
Document Date: July 3, 2021
Submitted by:
Mohamed Omar Ismail
PhD Candidate
Faculty of Dentistry
Minia University

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Soft tissue augmentation by xenogeneic collagen matrix versus 
subepithelial connective tissue graft around early implant placement in 
maxillary esthetic zone 
 
Proposal Submitted to 
Oral Medicine, Oral Diagnosis and Periodontology Department, 
Faculty of Dentistry, Minia University 
 
In partial fulfillment of the requirement of the doctoral Degree in 
Periodontology 
 
Presented by 
Mohamed Omar Ismail 
 BCH 2010 MD 2018  
Faculty of Dentistry 
Minia University 
2021 
 
 
 

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Under Supervision 
Of 
 
Prof Dr Mohamed Abdel Moniem Ebrahem 
Professor of Oral Medicine, Oral Diagnosis and Periodontology 
Faculty of Dentistry, Minia University 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Introduction  
 
      Dental implants have been considered a good option for partially 
edentulous patients in maintaining healthy mucosa with minimal crestal bone 
loss and no extensive harm to the adjacent natural teeth (Henry, P. J, 2000). 
 
      Three basic protocols for implant placement were defined according to the 
time between tooth extraction and implant installation; in the type-1 protocol 
(immediate implant installation), implants are placed in fresh extraction 
sockets, with the aim to engage the remaining socket walls with the implant. 
In the type-2 protocol (early implant placement), implants are placed 
approximately 4–8 weeks after tooth extraction. The main objective of this 
protocol is to ensure the lack of pathology when placing the implant and, at 
the same time, to optimize the availability of soft tissue for primary healing 
and probable lateral bone augmentation. In the type-3 protocol (early-
delayed/conventional implant placement) the implants are placed once most of 
the dimensional changes in the alveolar ridge have occurred (12–16 weeks) 
(Lanza et al., 2015). 
 
      The early implant-placement protocol has been suggested because it shares 
some of the advantages of immediate placement, such as using bone volume 
immediately after extraction, although already in the second month there is 
alveolar bone loss; it also allows for the primary closure (epithelium-
connective tissue) of the wound. It is indicated in the presence of acute 
infectious processes; early implant placement is associated with a lower 
frequency of mucosal recession compared to immediate placement, when 
combined with regeneration procedures (Sanz et al., 2012). 
      Implant therapy in the anterior maxilla is challenging for the clinician 
because of the esthetic demands of patients and difficult pre-existing anatomy 

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(Ebenezer et al., 2015). Placement of dental implant in the esthetic zone is a 
technique sensitive procedure with a little room for error (Al-Sabbagh et al 
2006). 
 
      Enough keratinized tissue was considered important for marinating healthy 
tissue around dental implant, Also soft tissue biotype has been considered as a 
critical factor, where patients would show either thin scalloped gingiva or 
thick flat biotype  Moreover, it has been proven that thin biotype had higher 
liability for gingival recession from any trauma during the surgical and 
prosthetic procedures in comparison to thick flat biotype and the underlying 
bone could suffer from rapid resorption in association with soft tissue 
recession (Elbattawy et al.,2020). 
 
      Consequently, plastic augmention procedures have been introduced to 
achieve better esthetics in conjunction with implant placement (Burkhardt & 
Lang 2014). There is consensus that the addition of soft tissue graft to the 
surgical implant protocol in patients with thin scalloped biotype increases 
gingival thickness and improves esthetic outcomes, especially at the buccal 
gingival margin level. It is likely to even improve longer-term soft tissue 
stability (Shetty & Bhat 2013). 
 
      Subepithelial Connective Tissue Graft has been widely utilized aiming at 
increasing the width and thickness of keratinized tissue either around natural 
teeth or around implants for resisting and treating recession, masking the 
metallic implant color and also for papillary reconstruction (Karthikeyan et 
al., 2016). Both free gingival and connective tissue grafts are however 
associated with significant patient morbidity due to the need for a donor palate 
site, that leaves the periosteum exposed after surgery. Unfortunately, high 
morbidity is common in all types of surgeries where autologous grafts are 

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involved (like bone grafting techniques), while xenogeneic materials do not 
present such inconvenience (Puri et al., 2019). 
 
     An ideal non autologous graft for soft tissue substitution should promote 
haemostasis, be infection resistant, favour the formation of granulation tissue, 
have a low post-operative morbidity and have a fast healing time (Maiorana 
et al., 2016). 
 
      Mucoderm® is a natural type I/III collagen matrix derived from porcine 
dermis that undergoes a multi-stage purification process to remove all non-
collagenous proteins and cells, as well as potential bacteria and viruses. These 
processing results in a three-dimensional stable matrix consisting of a 
naturally cross-linked open porous collagen network that serves as a scaffold 
for the adhesion and migration of connective tissue cells and blood vessels 
(Pabst et al. 2015). Thus, mucoderm® supports revascularization, fast soft 
tissue integration and offers a safe alternative to the autologous connective 
tissue (Schmitt et al. 2016, Zafiropoulos et al. 2016, Rossi et al. 2016). 
 
Mucoderm will be used in this study as axenogenic collagen matrix for soft 
tissue augmentation in maxillary esthetic zone  
    
 
 
 
 
 
 
 
 

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Aim of the study 
 
The aim of this study is to compare the clinical and radiographic 
outcomes of xenogeneic collagen matrix to Subepithelial Connective Tissue 
Graft in maintaining crestal bone and enhancing soft tissue around early 
implant placement in maxillary anterior zone  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Patients and methods 
 
Patient selection 
This investigation will be included 12 implants placed in 12 patients with 
missing maxillary tooth in the esthetic zone Subjects will be selected from the 
outpatient clinic, Department of oral Medicine and Periodontology, Faculty of 
Dentistry, Minia University. 
Inclusion criteria: 
1-Selected patients of both sexes are 25-55 years old. 
2-Patient will be free from any systemic diseases that might affect healing,or 
complicate the surgical procedures according to modified Cornell Medical 
Index(Glick M.,2003) 
3- Thin tissue biotype ,Trans-gingival periodontal examination will be made 2, 
4 and 6 mm apical to the gingival margin at the mesiolabial and distolabial 
line angle as well as midlabial (Cuny-Houchmand et al., 2013) 
4- Cooperative, motivated, and hygiene conscious patients. 
Exclusion criteria: 
1- Pregnant women. 
2-Smokers 
3-Precense of persistent chronic infection in the implant site. 
4- Patient at growth phase with partially erupted teeth 
5- Patient with para-functional habits that produce overload on the implant 
such as bruxism and clenching 
6- Patient with insufficient vertical inter-arch space upon centric occlusion to 
accommodate the available restorative component 
Ethical regulation 
The complete treatment plan will be explained to all patients including 
detailed steps, risks, and expected results and their full signed consent will be 
obtained prior to entry into study. The study will be complied with the rules 

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set by the International Conference on Harmonization Good Clinical Practice 
Guidelines, and the Declaration of Helsinki and the research ethics committee 
of the Faculty of Dentistry, Minia University. 
Clinical evaluation:  
Patients will be evaluated clinicaly and radiographically along the course of 
the study at basline, 6, 12 months after the implant insertion. 
The following records will be performed:  
1-Clinical photographs, Study casts at baseline. 
2-A preoperative cone beam computed tomography (CBCT) will be 
performed for each patient prior to the surgery to determine bone height and 
width and decide the implant length and diameter to be placed and to evaluate 
the underlying bone condition. 
3-Full mouth periodontal parameters will be recorded using William% 
graduated periodontal probe to evaluate the periodontal status (plaque index, 
gingival index, pocket depth, clinical attachment loss). 
4-Trans-gingival probing will be done at the mesial line angle 2, 4 and 6 mm 
apical to the gingival margin. At the same apico-coronal direction three points 
will be recorded at the mid-buccal and at the distal line angle (Rotenberg & 
Tatakis, 2014). 
5-The width of keratinized gingiva will be measured using graduated 
periodontal probe and recorded as the distance from the mucogingival junction 
to the gingival margin 
Assessment methods: 
Patients will be evaluated clinically and radiographically along the course of 
the study (immediate after the implant insertion) at bassline 0, 6 and12 
months. 
Clinical assessment: 
Clinical parameters will be included: gingival thickness (GT), keratinized 
tissue width (KTW) 

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GT will be measured by trans gingival-piercing of the tissues using an 
anesthetic needle with a rubber stopper 2mm coronal to the MGJ and in the 
mid distance mesio-distally. KTW will be measured at the mid buccal area 
from the gingival crest to the MGJ 
Treatment plan:  
All procedures will be done under completely aseptic conditions.  
Patients will be anaesthetized by buccal and palatal infiltration. 
Crestal incision and full thickness mucoperiosteal flap will be elevated 
buccally and lingually. Then the bone width will be measured again using 
bone caliper to confirm the implant width as detected in CBCT.  
Sequential drilling will be started by the pilot drill till the last drill that suited 
the planned implant size. Before implant placement a parallel pin will be used 
to check the implant parallelism.  
Implant insertion will be done in the osteotomy site using torque wrench by 
self-tapping fashion till the implant will be placed 0.5-1mm below the alveolar 
bone crest with adequate primary stability 
The site will be prepared to receive the graft and allow its fixation. 
Randomization 
The study will be used simple randomization to allocate patients into test and 
control groups. 
Then, random allocation will be performed using computer-generated random 
numbers to determine which group they will be assigned  
Group1 (control group): 
SCTG will be from the palate by single incision technique .The SCTG will be 
placed in the pouch over the recipient site below the labial/buccal flap and 
extending palatally. The graft will be sutured in a horizontal mattress manner 
to the labial/buccal flap .The palatal wound from which the SCTG harvested, 
will be sutured by sterilized, natural non absorbable silk  
Group2 (test group): 

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The matrix was shaped to match the desired size in the recipient bed. 
Radiographic assessment: 
-Radiographic evaluation will be performed for all patients at baseline, 6and12 
months following treatment by using cone beam CT 
Post-Operative Care: 
post operatively Antibiotic cover will be prescribed in the form of 
Amoxicillin–clavulanate 
potassium 
(Augmentin) 
2x1000mg/day 
and 
ketoprofen 150 mg twice per day for 5 days after implant insertion, All 
patients were asked to perform the following measures after each surgical 
time: Cold packs for the first 3 hours, Soft diet for the first week, warm 
chlorhexidine gluconate 0.1% mouth wash twice per day in the second post-
operative day and was continued for two weeks, Avoid touching of the 
surgical site while brushing and eating. The sutures were removed after 7 - 10 
days post-surgically, one week later the operation site was again checked to 
ensure complete soft tissue healing. Implants loading will be done 4 months 
after placement and final prosthesis be delivered. 
Statistical analysis: 
-All data will be tabulated and analyzed by statistical method 
 
 
 
 
 
 
 
 
 
 
 

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References 
 
Al-Sabbagh, Mohanad. "Implants in the esthetic zone." Dental Clinics 50.3 
(2006): 391-407. 
 
Bhat, Vinaya, and Sonali Shetty. "Prevalence of different gingival biotypes 
in individuals with varying forms of maxillary central incisors: A 
survey." Journal of Dental implants 3.2 (2013): 116. 
 
Burkhardt, Rino, and Niklaus P. Lang. "Fundamental principles in 
periodontal 
plastic 
surgery 
and 
mucosal 
augmentation–a 
narrative 
review." Journal of clinical periodontology 41 (2014): S98-S107. 
 
Cuny-Houchmand, M., Renaudin, S., Leroul, M., Planche, L., Le 
Guehennec, L., & Soueidan, A. (2013). Gingival biotype: The probe test 
utility.
 
 
Ebenezer, V., Balakrishnan, R., Muthumani, T., & Prakash, D. 
 "Determination of Implant Length in Maxillary Anterior Region." Biomedical 
and Pharmacology Journal 8.October Spl Edition (2015): 487-490. 
 
Elbattawy, W., Kamal, M., Eiid, S. B., & Shoeib, M. "Clinical Evaluation 
of platelet rich fibrin versus subepithelial connective tissue graft, for soft 
tissue augmentation around implant in the aesthetic zone: A randomized 
control clinical trial." Egyptian Dental Journal 66.4-October (Oral Medicine, 
X-Ray, Oral Biology & Oral Pathology) (2020): 2187-2195. 
 

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Glick, M. I. C. H. A. E. L., MICHAEL A. Siegel, and VERNON J. 
Brightman. "Evaluation of the dental patient: diagnosis and medical risk 
assessment." Burkit’s oral medicine diagnosis and treatment. Hamilton, 
Ontario: BC Decker Inc (2003): 5-35.
 
 
Henry, P. J. "Tooth loss and implant replacement." Australian dental 
journal 45.3 (2000): 150-172). 
 
Karthikeyan, B. V., Khanna, D., Chowdhary, K. Y., & Prabhuji, M. l. 
"The 
versatile 
subepithelial 
connective 
tissue 
graft: 
a 
literature 
update." General dentistry 64.6 (2016): e28-e33. 
 
Lanza, A., Scognamiglio, F., Femiano, F., & Lanza, M. "Immediate, early, 
and conventional implant placement in a patient with history of 
periodontitis." Case reports in dentistry 2015 (2015). 
 
Maiorana, C., Beretta, M., Pivetti, L., Stoffella, E., Grossi, G. B."Use of a 
collagen matrix as a substitute for free mucosal grafts in pre-prosthetic 
surgery: 1 year results from a clinical prospective study on 15 patients." The 
Open Dentistry Journal 10 (2016): 395. 
 
Pabst AM, Wagner W, Kasaj A, Gebhardt S, Ackermann M, Astolfo A, 
Marone F, Haberthür D, Enzmann F, Konerding MA. Synchrotron-based 
X-ray tomographic microscopy for visualization of three-dimensional collagen 
matrices. Clin Oral Investig. 2015 Mar;19(2):561-4.  
Puri, K., Kumar, A., Khatri, M., Bansal, M., Rehan, M., & Siddeshappa, 
S. T.  "44-year journey of palatal connective tissue graft harvest: A narrative 
review." Journal of Indian Society of Periodontology 23.5 (2019): 395. 

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Rossi Alessandro Luigi, Palombo David, Capilupi Vincenzo, Chiapasco 
Matteo. Soft tissue healing with a new xenogenic collagen matrix in post-
extractive socket sealing procedures: preliminary results of a prospective 
cohort study. SIdP Congress 2016. 
 
Rotenberg, Shaun A., and Dimitris N. Tatakis. "Dimensional changes 
during 
early 
healing 
after 
a 
subepithelial 
connective 
tissue 
graft 
procedure." Journal of periodontology 85.7 (2014): 884-889. 
 
Sanz, I., Garcia‐Gargallo, M., Herrera, D., Martin, C., Figuero, E., & 
Sanz, M. "Surgical protocols for early implant placement in post‐extraction 
sockets: a systematic review." Clinical Oral Implants Research 23 (2012): 67-
79. 
 
Schmitt CM, Matta RE, Moest T, Humann J, Gammel L, Neukam FW, 
Schlegel KA. Soft tissue volume alterations after connective tissue grafting at 
teeth: the subepithelial autologous connective tissue graft versus a porcine 
collagen matrix - a pre-clinical volumetric analysis. J Clin Periodontol. 2016 
Jul;43(7):609-17.  
 
Zafiropoulos GG, Deli G, Hoffmann O, John G. Changes of the 
peri-implant soft tissue thickness after grafting with a collagen matrix. J 
Indian Soc Periodontol 2016; 20:441-5.