Enhancing Soft Tissues Around Inserted Implants by Two Different Methods
ConditionMissing Teeth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorDamascus University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18 years or older.
Good oral hygiene, defined as full-mouth plaque score ≤25%.
Having a single missing tooth in the aesthetic zone of the maxilla.
Tooth extraction occurred at least 3 months prior to enrolment.
Disqualifiers
Systemic diseases.
Smoking.
Periodontal disease.
Untreated caries lesions.
Trial design
Design model
Parallel
Treatments tested in this trial
Peri-implant soft tissue augmentation using connective tissue graft
Procedure/SurgeryA 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.
Peri-implant soft tissue augmentation using xenogenic collagen matrix
Procedure/SurgeryA 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Connective tissue graft groupActive comparator 1 intervention
Group B: Xenogeneic collagen matrix groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 postoperativelySecondary outcomes
1
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 postoperatively2
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.3
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 postoperatively4
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.Sponsors and contacts
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Source ClinicalTrials.gov