CTG Versus Collagen Matrix for Peri-Implant Soft Tissue Augmentation
Trial statusNot yet recruiting
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
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: