Comparing Collagen Matrix and Free Gingival Graft for Improving Gum Tissue Around Dental Implants
Randomized Trial Measuring Soft Tissue Changes and Patient Experience Over Two Years
Led by Mohammed Bin Rashid University of Medicine and Health Sciences · Updated on 2025-12-04
30
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the differences between xenogeneic collagen matrices XCM and free gingival grafts FGG for improving the soft tissue around dental implants. The goal is to see how each method affects the width and thickness of keratinized mucosa KM, which helps protect the implant area from tissue recession and damage. This trial will measure both clinical outcomes and patient experiences over short-term 6 months and long-term 1 and 2 years periods.
Participants will be randomly assigned to receive either XCM or FGG soft tissue augmentation at the time of healing abutment connection around dental implants. The XCM is a collagen matrix designed to reduce patient discomfort and surgery time, while FGG is a traditional graft taken from the patients own tissue. Follow-up visits will occur at baseline, 2 weeks, and at 1, 3, 6, 12, and 24 months after surgery to assess tissue changes and other health indicators.
During the study, patients will undergo clinical evaluations including measuring KM width, thickness, and tissue height using intraoral scans and digital models. Patient-reported outcomes like pain and satisfaction will be recorded shortly after surgery and at 3 years. Additional assessments will track plaque, bleeding, probing depth, bone levels, and implant survival. The total participation may last up to two years with multiple checkups and monitoring of tissue health.
CONDITIONS
Brief Title
Efficacy of Collagen Matrix for Peri-implant Soft Tissue Phenotype Modification
Research Team
M
Maanas shah, BDS MSD CAGS MRACDS
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Mohammed Bin Rashid University of Medicine and Health Sciences
Lead Sponsor
Who Can Participate
Age: 21Years +
All Genders
Eligibility Criteria
You may qualify if you...
Aged 21 or over
Insufficient keratinized mucosa (less than 2 mm) at the implant site during healing abutment placement
Controlled oral hygiene with plaque and bleeding scores 25% or less at baseline
Good compliance and willingness to attend follow-up visits
Willing to provide informed consent
You will not qualify if you...
Current smoking
Untreated localized or generalized periodontal disease
Uncontrolled systemic diseases
Long-term use of non-steroidal anti-inflammatory drugs
History of cancer, radiotherapy, or chemotherapy
Allergy to collagen
History of mucogingival surgery
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants undergo soft tissue augmentation around dental implants at the time of healing abutment connection using either a collagen matrix substitute or a free gingival graft to modify the peri-implant soft tissue phenotype.
Multiple visits over 6 months for treatment and assessments
Follow-up
Duration - Up to 2 years
Participants are monitored for clinical changes in keratinized mucosa width, thickness, and supracrestal tissue height after soft tissue augmentation.
Periodic follow-up visits up to 2 years for long-term assessment
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Clinical evaluation of a new collagen matrix (Mucograft prototype) to enhance the width of keratinized tissue in patients with fixed prosthetic restorations: a randomized prospective clinical trial.
Volumetric and linear changes at dental implants following grafting with volume-stable three-dimensional collagen matrices or autogenous connective tissue grafts: 6-month data.
A multi-centre randomized controlled trial comparing connective tissue graft with collagen matrix to increase soft tissue thickness at the buccal aspect of single implants: 1-year results.
Jan Cosyn, Célien Eeckhout, Thomas De Bruyckere...