CTG Versus Collagen Matrix for Peri-Implant Soft Tissue Augmentation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collagen Matrix, Connective Tissue Graft.
- Who it may be relevant to
- Registry conditions: Peri-implant Soft Tissue Deficiency, Insufficient Peri-implant Keratinized Tissue. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Results of Soft Tissue Grafting Around Implant in the Mandible Molar Area
Overview
This randomized controlled trial compares two techniques for peri-implant soft tissue augmentation in the mandibular molar region: an autogenous connective tissue graft (CTG) and a collagen matrix. Adult patients requiring implant treatment with insufficient peri-implant soft tissue thickness will be randomly assigned to receive either CTG or a collagen matrix at the time of implant surgery. The study aims to evaluate and compare changes in peri-implant soft tissue thickness, width of keratinized tissue, and soft tissue contour over a 9-month follow-up period, as well as the occurrence of postoperative complications. The results of this study will help determine whether a collagen matrix can provide clinical outcomes comparable to those of connective tissue grafting for peri-implant soft tissue augmentation.
Detailed description
This randomized controlled trial is designed to compare two approaches for peri-implant soft tissue augmentation in the mandibular molar region: an autogenous connective tissue graft (CTG) and a collagen matrix. Adult patients with insufficient peri-implant soft tissue thickness will be enrolled and randomly allocated in a 1:1 ratio to receive either CTG or a collagen matrix at the time of implant surgery. Randomization will be performed using a block randomization method, and outcome assessment will be conducted by a blinded examiner.
Clinical and digital evaluations will be performed at predefined time points, including baseline and follow-up visits up to 9 months after surgery. Peri-implant soft tissue thickness, width of keratinized tissue, and soft tissue contour changes will be assessed using standardized clinical measurements and digital workflows based on intraoral scanning and cone-beam computed tomography where indicated. Postoperative healing and adverse events will be monitored throughout the follow-up period.
The study is conducted at a single academic center and is intended to provide comparative clinical data on the effectiveness and safety of collagen matrix versus connective tissue grafting for peri-implant soft tissue augmentation.
Interventions
- Device Collagen Matrix
A porcine-derived collagen matrix is used for peri-implant soft tissue augmentation at the time of implant surgery, serving as a substitute for autogenous connective tissue grafting. - Procedure Connective Tissue Graft
An autogenous connective tissue graft harvested from the patient is used for peri-implant soft tissue augmentation at the time of implant surgery.
Primary outcome measures
- Change in peri-implant soft tissue thickness [Time frame: Baseline (before surgery) to 9 months after surgery]
Secondary outcome measures (3)
- Change in width of peri-implant keratinized tissue [Time frame: Baseline to 9 months after surgery]
- Change in peri-implant marginal bone level [Time frame: Baseline to 9 months after surgery]
- Peri-implant clinical indices [Time frame: Up to 9 months after surgery]
Eligibility criteria
Inclusion criteria
Adults aged 18 to 65 years.
Patients requiring dental implant treatment in the mandibular molar region.
Presence of insufficient peri-implant soft tissue thickness (< 2 mm).
Adequate general health to undergo minor oral surgery.
Ability and willingness to provide written informed consent and comply with study procedures.
Exclusion criteria
Systemic conditions or medications that may impair wound healing.
Heavy smoking (more than 10 cigarettes per day).
History of allergy or hypersensitivity to collagen-based materials.
Previous graft failure or complications at the intended implant site.
Loss of three or more adjacent teeth in the study area (excluding third molars).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Vietnam · 1 center
- Hanoi Medical University — Hanoi
Identifiers
NCT: NCT07371481 · 01250159