Collagen matrix versus gum graft to increase keratinized tissue around dental implants
Official title: Efficacy of Collagen Matrix for Peri-implant Soft Tissue Phenotype Modification: A Randomized Controlled Trial
Run by Mohammed Bin Rashid University of Medicine and Health Sciences · NCT07056959 · Data updated 2026-11-12
This trial will test whether a xenogeneic collagen matrix works as well as a free gingival graft to increase keratinized gum tissue around dental implants in adults with less than 2 mm of keratinized mucosa.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Mohammed Bin Rashid University of Medicine and Health Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Dubai) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | December 2027 |
| Study ends | June 2028 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT07056959 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥21 years) with dental implants showing insufficient buccal keratinized mucosa (<2 mm) at the time of healing abutment placement, good oral hygiene, and willingness to attend follow-up visits are ideal candidates.
✕Probably not a fit
Smokers, patients with uncontrolled periodontal or systemic disease, those with collagen allergy or prior mucogingival surgery, and people who already have adequate keratinized tissue are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial will enroll 30 adults at Dubai Dental Hospital and randomly assign them to receive either a xenogeneic collagen matrix (XCM) or a free gingival graft (FGG) at the time of healing abutment connection to augment peri-implant keratinized mucosa. Clinical outcomes (keratinized mucosa width, mucosal recession, and attachment levels) and patient-reported outcome measures will be collected at 6 months, 1 year, and 2 years. The protocol standardizes surgical technique, excludes smokers and patients with uncontrolled systemic or periodontal disease, and requires good baseline oral hygiene. The aim is to compare surgical results, healing, and patient comfort between the two approaches.
Why it matters
Potential benefit: If successful, this could offer a less invasive option that achieves similar gum width with less pain and shorter surgical time compared with harvesting an autogenous graft.
How similar studies have gone: Free gingival grafts are the established gold standard and several smaller trials have reported that collagen matrices can give comparable short-term increases in keratinized mucosa, but long-term comparative evidence is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 21 or over. * Insufficient KM width (\< 2 mm) at the buccal aspect of implants at time of healing abutment placement, either for single anterior or posterior implants. * Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline). * Good compliance and commitment to attend follow-up review appointments. * Willing to provide informed consent. Exclusion Criteria: * Smoking * Untreated localized or generalized periodontal diseases * Uncontrolled systemic diseases * Long term use of non-steroidal anti-inflammatory medications * History of malignancy, radiotherapy or chemotherapy * Collagen allergy * History of mucogingival surgery
Where it's running
-
Dubai Dental Hospital
Dubai, United Arab Emirates Recruiting
Study contacts
- Study coordinator: Maanas shah, BDS MSD CAGS MRACDS
- Email: maanas.shah@dubaihealth.ae
- Phone: 971556102178
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.