Enhancing Soft Tissues Around Inserted Implants by Two Different Methods
Recruiting now · Not applicable
Conditions studied: Missing Teeth
In brief
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.
Key facts
- Study ID
- NCT06837688
- Run by
- Damascus University
- People needed
- 30
- Starts
- 2025-03-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-03-05
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
- Having adequate bone volume for implant placement (bucco-palatal bone dimension of at least 6 mm).
- Having at least 5 mm of keratinized tissue width at the implant site.
You may not qualify if…
- Systemic diseases.
- Smoking.
- Periodontal disease.
- Untreated caries lesions.
- Need for horizontal bone augmentation at the time of implant placement.
Where it is running
- Damascus University — Damascus, Syria (enrolling)
Full record on ClinicalTrials.gov
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