Peri-implant Soft Tissue Deficiency, Insufficient Peri-implant Keratinized Tissue
Conditions
Keywords
Peri-implant soft tissue augmentation, Connective tissue graft, Collagen matrix, Dental implant
Brief summary
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
DEVICECollagen 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.
PROCEDUREConnective 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.
Sponsors
Hanoi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessment is performed by an independent examiner who is blinded to group allocation.
Intervention model description
Participants are randomly assigned in a 1:1 ratio to one of two parallel groups to receive either a connective tissue graft or a collagen matrix for peri-implant soft tissue augmentation, with no crossover between groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in peri-implant soft tissue thickness | Baseline (before surgery) to 9 months after surgery | Change in peri-implant soft tissue thickness measured using standardized digital methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in width of peri-implant keratinized tissue | Baseline to 9 months after surgery | Change in the width of keratinized tissue around the implant measured clinically using standardized procedures. |
| Change in peri-implant marginal bone level | Baseline to 9 months after surgery | Changes in marginal bone level assessed using cone-beam computed tomography where indicated. |
| Peri-implant clinical indices | Up to 9 months after surgery | Assessment of peri-implant inflammation using standardized clinical indices. |
Countries
Vietnam
Contacts
CONTACTPhu Manh Nguyen, DDS, MSc
Outcome results
None listed