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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
46
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.
An autogenous connective tissue graft harvested from the patient is used for peri-implant soft tissue augmentation at the time of implant surgery.
Hanoi Medical University
Hanoi, Vietnam
Change in peri-implant soft tissue thickness
Change in peri-implant soft tissue thickness measured using standardized digital methods.
Time frame: Baseline (before surgery) to 9 months after surgery
Change in width of peri-implant keratinized tissue
Change in the width of keratinized tissue around the implant measured clinically using standardized procedures.
Time frame: Baseline to 9 months after surgery
Change in peri-implant marginal bone level
Changes in marginal bone level assessed using cone-beam computed tomography where indicated.
Time frame: Baseline to 9 months after surgery
Peri-implant clinical indices
Assessment of peri-implant inflammation using standardized clinical indices.
Time frame: Up to 9 months after surgery
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