CTG Versus Collagen Matrix for Peri-Implant Soft Tissue Augmentation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHanoi Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Collagen Matrix
DeviceA 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.
Connective Tissue Graft
Procedure/SurgeryAn autogenous connective tissue graft harvested from the patient is used for peri-implant soft tissue augmentation at the time of implant surgery.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Connective Tissue Graft (CTG)Active comparator 1 intervention
Group B: Collagen MatrixExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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 surgery2
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 surgery3
Peri-implant clinical indices
Assessment of peri-implant inflammation using standardized clinical indices.
Time frame
Up to 9 months after surgeryOther outcomes
1
Postoperative complications and adverse events
Incidence of postoperative complications, including soft tissue necrosis, infection, bleeding, implant failure, and other adverse events.
Time frame
Up to 9 months after surgerySponsors and contacts
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Source ClinicalTrials.gov