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

Sponsor: Ankara University • ClinicalTrials.gov ID: NCT07782125

Registry updated: 2026-08-24

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Description

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.

Interventions

Connective tissue graft (Procedure)
An autogenous connective tissue graft harvested from the palate using the extraoral de-epithelialization technique will be placed over the crest beneath the buccal flap and stabilized with simple interrupted sutures (6-0 polypropylene) to augment peri-implant soft-tissue thickness. (control group)
Volume-stable collagen matrix (Device)
A volume-stable porcine-derived collagen matrix (15×20×3 mm) will be trimmed to the defect size, placed over the crest beneath the buccal flap, and stabilized with simple interrupted sutures (6-0 polypropylene) to augment peri-implant soft-tissue thickness. (test group)

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

Conditions

Dental Implantation Peri-Implant Soft Tissue Deficiency Soft Tissue Augmentation

Locations

Faculty of Dentistry, Ankara University — Ankara, Yeni̇mahalle, Turkey (Türkiye)

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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