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Active, not recruiting Not applicable

A Comparative Clinical Study Between a Collagen Matrix and Collagen Membrane as Wound Protection During Ridge Preservation ARP

NCT06029322 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2024-01-02
Last updated
2025-09-15

Condition(s) studied

Oral Soft Tissue Conditions

Investigational drug(s) / intervention(s)

Socket seal after alveolar ridge preservation

Socket seal after alveolar ridge preservation: Socket seal is performed after ARP. Using a collagen matrix or membrane the socket is sealed, at the control (membrane) site a small pouch is made at the buccal and lingual aspect. Monofilament sutures are used to secure the respective material in place.

Study summary

Patients in need of extraction of two teeth in combination with alveolar ridge preservation will be invited to participate in intra-subject RCT on ARP. Prior to surgery, a small-field low-dose CBCT is taken.

18 patients will be included, each contributing 1 surgical site to each treatment arm.

Since this study is a intra-subject RCT randomization of the surgical site will be performed just after ARP by a coin flip. Randomization is concealed for the evaluating examiner and statistician.

After ARP the collagen matrix or collagen membrane is used to seal the coronal aspect of the extraction socket.

Soft tissue thickness in centre of the site will be determined using CBCT. Secondary outcomes include: Wound dimensions, socket wound healing score, changes in bone and soft tissue dimensions and changes in buccal soft tissue profile

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * At least 21 years old * Good oral hygiene defined as a full-mouth plaque score ≤ 25% (O'Leary, Drake, \& Naylor, 1972) * Need for ARP after tooth extraction at two sites in the maxilla or mandible with \> 50% buccal bone present following tooth extraction * Signed informed consent Exclusion Criteria: * Any systemic disease * Pregnancy * Smoking (will be specifically asked) * Untreated periodontitis * Untreated caries lesions * Suppuration and/or active infection around the failing tooth * Midfacial recession at the failing tooth

Primary outcome measure(s)

  • Soft tissue thickness in the centre of the site — pre-op, 4 months
    Changes in the soft tissue thickness at the centre of the site measured on CBCT

Trial sites (1)

FacilityCityRegionStatus
Ghent University Hospital Ghent East Flanders
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06029322 on ClinicalTrials.gov ↗ ← All trials in Belgium