Using collagen matrix to preserve donor area after gum tissue harvesting

Use of a Double-layered Collagen Matrix for Preservation of the Maxillary Tuberosity Area Upon Free Connective Tissue Graft Harvesting

This study is testing if using a special collagen matrix helps people heal better after having gum tissue taken from their mouth compared to standard healing methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: I.M. Sechenov First Moscow State Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Moscow)
• Trial ID: NCT06039839 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of using a double-layer collagen matrix versus standard healing methods in preserving the donor area after harvesting connective tissue grafts from the maxillary tuberosity. A total of 30 patients will be randomly assigned to one of two groups: one will heal without the collagen matrix, while the other will have the wound defect closed with the collagen matrix 'FibroMATRIX'. The study will assess various outcomes, including volumetric changes in the donor area, pain levels, postoperative edema, bleeding, analgesic use, and quality of life during recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 45 with soft tissue thickness deficiencies in the maxillary or mandibular areas requiring augmentation.

Not a fit: Patients with previous graft harvesting from the same donor area or those with significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve healing outcomes and reduce complications for patients undergoing dental implant procedures.

How similar studies have performed: While similar approaches have been explored, this specific use of the collagen matrix in this context is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Presence of written informed consent of the patient to participate in the study;
2. Age between 18 and 45 years;
3. Included defects on the maxilla or mandible within 1-2 teeth combined with soft tissue thickness deficiency in the area of dental implants (\< 2 mm);
4. Teeth without periodontal pathology, probing depth should not exceed 3 mm across the entire dentoalveolar sulcus;
5. Satisfactory level of oral hygiene;
6. Absence of general diseases in the stage of exacerbation or decompensation

Non-inclusion criteria:

1. Patients who had previous harvesting of CTG from the same donor area;
2. Patients with impacted third molars in the donor area;
3. Presence of concomitant diseases in the stage of exacerbation or decompensation;
4. Patients with oncological diseases, as well as patients who have received radiotherapy and chemotherapy in the last 5 years;
5. Patients with a history of smoking for more than 10 years.

Exclusion Criteria:

1. Patient refusal of further participation in the study;
2. Pregnant and breastfeeding women;
3. Patients with blood coagulation disorders (haemophilia, Willebrand's disease, intake of anticoagulants);
4. Patients with diseases that impair soft tissue healing (insulin-dependent diabetes mellitus).

Where this trial is running

Moscow

• I.M. Sechenov First Moscow State Medical University (Sechenov University) — Moscow, Russian Federation (Recruiting)

Study contacts

• Principal investigator: Igor Ashurko — I.M. Sechenov First Moscow State Medical University (Sechenov University)
• Study coordinator: Igor Ashurko

Conditions Soft Tissue Atrophy; connective tissue graft; xenogeic collagen matrix; increasing of soft tissue thickness; dental implant; soft tissue augmentation; donor site