An interventional study of Peri-implant soft tissue augmentation using connective tissue graft and Peri-implant soft tissue augmentation using xenogenic collagen matrix in Missing Teeth, sponsored by Damascus University. Active, not recruiting at 1 site in Syria. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
This randomized controlled clinical trial investigates the efficacy of xenogeneic collagen matrix (XCM) versus autogenous subepithelial connective tissue graft (SCTG) in enhancing the peri-implant soft tissue profile around single dental implants in the aesthetic zone of the anterior maxilla. Thirty adult patients with a single missing tooth, adequate bone volume, and sufficient keratinized tissue will be recruited at Damascus University. Each patient will undergo a fully digital workflow for implant planning-including CBCT imaging, intraoral scanning, and CAD/CAM fabrication of a surgical guide and provisional restoration-to ensure precision in implant placement. Immediately following implant insertion, patients will be randomly allocated (1:1) to either receive a CTG harvested from the palatal mucosa using a single incision technique or an XCM (Mucoderm®, Botiss Biomaterials) that is adapted and secured to the buccal mucosa. The primary outcome is the increase in buccal soft tissue profile, measured via superimposed digital surface models at baseline, immediately postoperatively, and at 3 months. Secondary outcomes include patient-reported measures (pain, edema, aesthetic satisfaction), clinical parameters (keratinized tissue width, soft tissue height), peri-implant health assessments, and radiographic assessment. By comparing these two methods, the study aims to determine whether the less invasive XCM can offer outcomes comparable to the CTG standard while reducing donor site morbidity and overall surgical time.
This clinical trial is designed to evaluate and compare the performance of two soft tissue augmentation techniques-autogenous subepithelial connective tissue graft (CTG) and xenogeneic collagen matrix (XCM, Mucoderm®)-when used concurrently with dental implant placement in the aesthetic zone of the anterior maxilla. The rationale for this study stems from the clinical challenge of achieving optimal soft tissue esthetics and function following tooth loss. While CTG has long been considered the gold standard for increasing peri-implant soft tissue thickness, it requires a secondary surgical site, which may lead to donor site morbidity, limited tissue availability, and increased surgical time. In contrast, XCM offers a promising alternative that is biocompatible, readily available, and less invasive.
Patients aged 18 years or older with a single missing tooth in the aesthetic zone, adequate bucco-palatal bone (≥6 mm), and at least 5 mm of keratinized tissue width will be considered eligible for the study. The enrollment process begins with a thorough screening process involving clinical and radiographic examinations, including a low-dose, small-field CBCT scan and an intraoral scan. These imaging modalities allow for accurate digital implant planning using specialized software, ensuring optimal implant positioning. The digital data will be used to fabricate a stereolithographic surgical guide and design a custom CAD/CAM screw-retained provisional restoration.
Following successful screening and informed consent, the surgical phase commences. Under local anesthesia, a full-thickness flap is elevated at the implant site. Guided by the digital plan, a dental implant is precisely positioned using the surgical guide. At this point, participants are allocated to one of two intervention groups based on a strict randomization protocol.
In the CTG group, a connective tissue graft is harvested from the palatal mucosa using the de- epithelialized free gingival graft technique. The harvested graft is then trimmed to match the dimensions of the recipient site and carefully positioned under the elevated flap to augment the soft tissue. The donor site is sutured using gelatin matrix to ensure proper healing. This technique, while effective, is associated with postoperative discomfort and additional surgical time due to the need for a second operative site.
Conversely, in the XCM group, soft tissue augmentation is achieved using a xenogeneic collagen matrix (Mucoderm®). The graft, initially measuring 15 × 20 mm, is first moistened in saline for 10 minutes and slightly compressed to adapt its thickness to the defect. After a superficial incision to release any muscle tension, the XCM is accurately positioned and secured to the buccal mucosa using single sutures. Following soft tissue augmentation, a screw-retained provisional restoration is attached immediately, contributing to both function and esthetics during the healing phase.
The primary outcome of the study is the increase in the buccal soft tissue profile, quantitatively assessed using intraoral scans to generate digital surface models at three critical time points: preoperatively (T0), immediately after surgery (T1), and 3 months postoperatively (T2). Secondary outcomes include clinical assessments-such as probing depth, plaque index, bleeding on probing, keratinized tissue width, graft dimensions, wound closure, surgery time, and complications-as well as radiographic evaluation of marginal bone loss. In addition, patient-reported outcome measures (PROMs), including postoperative pain, swelling, aesthetic satisfaction, and willingness to undergo the same treatment again, will be recorded using validated visual analogue and Likert scales. Aesthetic outcomes, including mid-facial recession, Pink aesthetic score, and mucosal scarring index, will also be documented.
The data will be analyzed on an intention-to-treat basis by an independent statistician. Statistical comparisons between the two groups will help determine whether the xenogeneic collagen matrix offers comparable or superior results to the autogenous connective tissue graft regarding soft tissue volume augmentation, esthetic outcomes, and patient satisfaction. Ethical approval has been obtained from the University of Damascus, and the trial follows the CONSORT guidelines. The results will be disseminated through peer-reviewed publications and presentations at professional conferences, contributing valuable evidence to the field of implant dentistry.
Overall, this study is expected to provide insight into whether XCM can serve as a reliable, less invasive alternative to CTG, thereby potentially enhancing patient outcomes and reducing the complications associated with donor site morbidity.
Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Patients receive soft tissue augmentation using an autogenous connective tissue graft. A full-thickness flap is elevated at the implant site, and after implant placement, a CTG is harvested from the palatal mucosa. The graft is then trimmed to the defect dimensions and positioned under the flap to augment the peri-implant soft tissue. The donor site is sutured with double-cross sutures to ensure proper healing
Procedure: Peri-implant soft tissue augmentation using connective tissue graft
Patients receive soft tissue augmentation using a xenogeneic collagen matrix (Mucoderm®). After implant placement and flap elevation, the XCM, initially sized at 15 × 20 mm, is moistened in saline for 10 minutes and slightly compressed. It is then adapted to the recipient site following a superficial incision to release muscle tension and secured to the buccal mucosa with single sutures. A screw-retained provisional restoration is installed immediately after surgery to support the augmented tissue.
Procedure: Peri-implant soft tissue augmentation using xenogenic collagen matrix
A full-thickness flap will be elevated after a crestal and sulcular incision at the single tooth gap and adjacent teeth. A surgical guide will be fitted and adjusted if needed. A dental implant will be placed as planned digitally in an optimal 3D position. A connective tissue graft (CTG) will be harvested from the palatal mucosa using the De-epithelialized free gingival graft technique and tailored to the site dimensions. The graft will be carefully positioned under the elevated flap to augment the soft tissue. The palatal wound will be sutured with double-cross sutures.
A full-thickness flap will be elevated after a crestal and sulcular incision at the single tooth gap and adjacent teeth. A surgical guide will be fitted and adjusted if needed. A dental implant will be placed as planned digitally in an optimal 3D position. The xenogenic collagen matrix, initially measuring 15 × 20 mm, is first moistened in saline for 10 minutes and slightly compressed to adapt its thickness to the defect. After a superficial incision to release any muscle tension, the XCM is accurately positioned and secured to the buccal mucosa using single sutures.
Increase in Buccal Soft Tissue Profile (BSP)
he BSP is defined as the volumetric change in the buccal soft tissue at the dental implant site. This outcome reflects both the thickness and contour improvements following soft tissue augmentation. Intraoral scans will be taken at three critical time points: preoperatively (T0), immediately postoperatively (T1), and 3 months postoperatively (T2). Digital surface models will be generated from these scans using specialized analysis software. The increase in BSP will be quantified as the difference in soft tissue volume (or thickness, depending on the analysis protocol) between the baseline (T0) and the 3-month follow-up (T2). Graft shrinkage will be measured between the scans immediately postoperatively (T1) and the 3-month follow-up (T2). his is a continuous variable measured in cubic millimeters (mm³) if volumetric data is used, or in millimeters (mm) if linear thickness is the chosen metric.
Time frame: T0: Preoperative baseline. T1: Immediately after surgery. T2: 3 months postoperatively
Probing Depth (PD)
* Definition: The distance from the gingival margin to the bottom of the peri-implant pocket measured around the implant. * Measurement: Using a UNC-15 periodontal probe at six sites around the implant. * Type: Continuous variable (measured in millimeters).
Time frame: Baseline (Preoperative), 3 months, and 6 months postoperatively
Plaque Index (PI)
* Definition: An ordinal score representing the level of plaque accumulation around the implant. * Measurement: Using a standardized modified plaque index (mPI). * Type: Ordinal variable.
Time frame: Baseline (Preoperative), 3 months, and 6 months postoperatively.
Bleeding on Probing (BOP)
* Definition: The presence or absence of bleeding upon gentle probing, indicating inflammation. * Measurement: Using a standardized modified bleeding index (mBI). * Type: Binary at each site, then aggregated.
Time frame: Baseline (Preoperative), 3 months, and 6 months postoperatively
Graft Dimensions
* Definition: The length, width, and thickness of the graft as applied. * Measurement: Recorded intraoperatively using a UNC-15 periodontal probe. * Type: Continuous variables (in millimeters).
Time frame: Recorded intraoperatively.
Wound Closure
* Definition: Wound closure is evaluated qualitatively (complete vs. incomplete). * Measurement: Wound closure is documented by the surgeon. * Type: Wound closure is categorical.
Time frame: Recorded intraoperatively.
Surgery Time
* Definition: Surgery time is the duration from the initial incision to the final suture placement. * Measurement: Surgery time is measured with a stopwatch. * Type: Surgery time is a continuous variable (in minutes).
Time frame: immediately following surgery
Complications
* Definition: Any adverse events such as infection, dehiscence, graft or implant loss. * Measurement: Documented by the surgical team and followed up clinically. * Type: Categorical (present/absent, with descriptive details).
Time frame: From intervention to the end of follow-up period at 6 months.
Radiographic Evaluation of Marginal Bone Loss
* Definition: The change in bone level around the implant measured from the implant shoulder to the first bone-to-implant contact. * Measurement: Using CBCT images. * Type: Continuous variable (in millimeters).
Time frame: Baseline (immediately postoperative), and 6 months postoperatively.
Postoperative Pain and Swelling
* Definition: Patient's subjective rating of pain and swelling after surgery. * Measurement: Using a visual analogue scale (VAS) ranging from 0 (no pain/swelling) to 10 (worst possible pain/swelling). * Type: Ordinal variable.
Time frame: One week postoperatively.
Aesthetic Satisfaction
* Definition: Patient's satisfaction with the aesthetic outcome of the implant restoration and surrounding soft tissue. * Measurement: Using a Likert scale (1-5, where 1 is very dissatisfied and 5 is very satisfied). * Type: Ordinal variable.
Time frame: 3 months postoperatively.
Willingness to Undergo the Same Treatment Again
* Definition: Patient's acceptance and perceived comfort of the treatment procedure. * Measurement: Assessed via a Likert scale (1-5, from not willing to very willing). * Type: Ordinal variable.
Time frame: 3 months postoperatively.
Mid-Facial Recession
* Definition: The vertical distance from the incisal edge of the implant-supported crown to the level of the buccal mucosal margin. * Measurement: Using a periodontal probe. * Type: Continuous variable (in millimeters).
Time frame: 3 and 6 months postoperatively.
Pink Aesthetic Score (PES)
* Definition: A composite score evaluating the harmony of the peri-implant soft tissue with adjacent teeth, based on criteria such as mesial/distal papilla, tissue level, contour, and color. * Measurement: Using a standardized scoring system (0-14 scale). * Type: Ordinal variable.
Time frame: 3 and 6 months postoperatively.
Mucosal Scarring Index (MSI)
* Definition: A measure of the presence and severity of scar formation at the graft site, based on criteria like color, contour, texture, and vascularity. * Measurement: Assessed using a categorical scoring system. * Type: Categorical variable.
Time frame: 3 and 6 months postoperatively.
Plan to share: No
Ran from Mar 2025 to primary completion in Jun 2026, 15 months.
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