Volume-stable collagen matrix vs. connective tissue graft for peri-implant soft-tissue defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized trial compares a volume-stable collagen matrix (VCMX) to autogenous connective tissue graft (CTG) for augmenting peri-implant soft tissue after single-tooth implant placement. Participants undergo standardized surgical procedures with evaluation of soft-tissue thickness, echo intensity, and blood flow using high-resolution intraoral ultrasound and Power Doppler, alongside clinical periodontal measures and patient-reported outcomes over six months. Histological and immunohistochemical analyses are planned from gingival biopsy samples at healing abutment placement to complement noninvasive assessments. The study aims to determine whether VCMX can provide similar esthetic and healing outcomes to CTG while avoiding a donor-site morbidity. Primary outcomes focus on changes in soft-tissue characteristics and healing at multiple time points.

Why it matters

Who can join: the full rules

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

Where it's running

• Faculty of Dentistry, Ankara University
  Ankara, Yeni̇mahalle, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Sivge Kurgan, PHD
• Email: sivgeakgun@gmail.com
• Phone: +905325495235

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using a collagen matrix to prevent bone loss during dental implant placement in the front teeth area.

  This study is testing whether a special collagen matrix can help prevent bone loss better than traditional tissue grafts during dental implant placement in the front teeth area for healthy adults.

  Recruiting Phase 2 Aristotle University Of Thessaloniki · Thessaloniki, Thessaloniki · NCT06622759

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.