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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connective Tissue Graft (CTG) | Active Comparator | Peri-implant soft tissue augmentation using autogenous connective tissue graft. |
|
| Collagen Matrix | Experimental | Peri-implant soft tissue augmentation using a collagen matrix. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen Matrix | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peri-implant soft tissue thickness | Change in peri-implant soft tissue thickness measured using standardized digital methods. | Baseline (before surgery) to 9 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in width of peri-implant keratinized tissue | Change in the width of keratinized tissue around the implant measured clinically using standardized procedures. | Baseline to 9 months after surgery |
| Change in peri-implant marginal bone level |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications and adverse events | Incidence of postoperative complications, including soft tissue necrosis, infection, bleeding, implant failure, and other adverse events. | Up to 9 months after surgery |
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phu Manh Nguyen, DDS, MSc | Contact | manhphu@hmu.edu.vn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanoi Medical University | Hanoi | Vietnam |
Individual participant data will not be shared because the dataset contains sensitive clinical and imaging information, and data sharing was not included in the approved study protocol or informed consent.
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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.
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Outcome assessment is performed by an independent examiner who is blinded to group allocation.
| Connective Tissue Graft | Procedure | An autogenous connective tissue graft harvested from the patient is used for peri-implant soft tissue augmentation at the time of implant surgery. |
|
Changes in marginal bone level assessed using cone-beam computed tomography where indicated.
| Baseline to 9 months after surgery |
| Peri-implant clinical indices | Assessment of peri-implant inflammation using standardized clinical indices. | Up to 9 months after surgery |