NCT07782125 Volume-Stable Collagen Matrix vs. Connective Tissue Graft for Peri-Implant Soft Tissue Defects
| NCT ID | NCT07782125 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ankara University |
| Condition | Dental Implantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 22 participants in total. It began in 2025-12-18 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age \>18 years * Periodontal health confirmed according to the 2017 World Workshop criteria (BOP \<10%, PD ≤3 mm, absence of gingival inflammation, and good oral hygiene) (Tonetti et al., 2018) * Requirement of implant placement and soft-tissue augmentation for a single missing tooth in the anterior region * Bleeding on probing \<30% at the adjacent teeth (Thoma et al., 2016) * Compliance with the study protocol and follow-up visits Exclusion Criteria: * Siebert Class II or Class III defects * History of surgery at the treated site * Untreated periodontitis or peri-implantitis * Current smoking or smoking within the previous five years * Systemic conditions (that may impair healing) * Pregnancy or lactation * Allergy to the materials/drugs used * Drug use affecting mucosal healing * History of antibiotic therapy within the previous six months
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07782125 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Dental Implantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07782125 currently recruiting?
Yes, NCT07782125 is actively recruiting participants. Contact the research team at sivgeakgun@gmail.com for enrollment information.
Where is the NCT07782125 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07782125 clinical trial?
NCT07782125 is sponsored by Ankara University. The trial plans to enroll 22 participants.