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Volume-Stable Collagen Matrix vs. Connective Tissue Graft for Peri-Implant Soft Tissue Defects

StatusRecruiting
PhaseNot applicable
Started2025-12-18
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 24, 2026 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.
Peri-implant soft-tissue defects will be treated with either a volume-stable collagen matrix (VCMX; test group) or an autogenous connective tissue graft (CTG; control group) following implant placement in patients with a single missing tooth. After a mid-crestal incision and full-thickness flap elevation, the graft material will be positioned over the crest beneath the buccal flap and stabilized, followed by tension-free primary closure. Peri-implant soft-tissue thickness, echo intensity, and vascularization will be assessed non-invasively using high-resolution intraoral ultrasonography and Power Doppler imaging. Clinical periodontal parameters and patient-reported outcomes, including pain perception (visual analog scale), swelling, fatigue, analgesic consumption, and wound healing, will be recorded. These outcomes will be evaluated at baseline and on the 1st week, 1st, 3rd, and 6th months. At the 6th month, gingival biopsy samples obtained during healing abutment placement will be evaluated histologically and immunohistochemically (CD11c, CD163, COL1, COL3, MMP-1, TIMP-1) to compare the biological integration of the two graft materials.
Trial Details
NCT Number NCT07782125
Lead Sponsor Ankara University
Conditions Dental Implantation, Peri-Implant Soft Tissue Deficiency, Soft Tissue Augmentation
Enrollment 22 participants
Start Date 2025-12-18
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-24