Clinical, Radiographic, and Digital Evaluation of the Effects of Autogenous Grafts on Peri-implant Mucosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKutahya Health Sciences University
About this trial
This study aims to evaluate the effects of autogenous grafts harvested from different palatal regions on the peri-implant mucosa when applied during second-stage dental implant surgery.
Clinical, radiographic, and digital assessment methods will be used to investigate the early effects of these grafts on peri-implant mucosal width and thickness. In addition, peri-implant tissue health and patient-reported outcomes will be evaluated to compare the effectiveness of the grafting techniques in peri-implant soft tissue management.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years
Systemically healthy patients
Presence of premolar or molar tooth loss in the mandible
Adequate mesiodistal and interocclusal space for implant and restoration placement
Disqualifiers
Poor oral hygiene
Uncontrolled periodontal disease
Pregnancy or lactation at any stage of the study
Uncontrolled diabetes mellitus
Trial design
Design model
Parallel
Treatments tested in this trial
Coronal palatal tissue
Procedure/SurgeryThis group will receive palatal grafts including marginal and interdental gingiva. This coronal palatal tissue will be applied to the peri-implant tissue at the second-stage implant surgery.
Apical palatal tissue
Procedure/SurgeryThis group will receive palatal grafts harvested from approximately 1.5 mm apical to the gingival margin. This graft will be applied to the peri-implant tissue at the second-stage implant surgery.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Coronal palatal tissueExperimental treatment 1 intervention
Group B: Apical palatal tissueActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Peri-implant Mucosal Thickness
The primary outcome is the change in peri-implant mucosal thickness measured at four time points using clinical and digital methods.
Time frame
Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading)Secondary outcomes
1
Keratinized Mucosa Width
Keratinized tissue width will be measured from the mid-buccal aspect of the edentulous area.
Time frame
Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading)2
Vestibular Depth
Vestibular depth is defined as the vertical distance between the midcrestal area and the point of greatest concavity of the mucosal fold.
Time frame
Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading)3
Modified Plaque Index
Modified plaque index will be measured at six points around each implant by an index with a minimum value of 0 and a maximum of 3.
Time frame
Postoperative 6th month after implant placement and 12th month after prosthetic loading4
Modified Bleeding Index
Modified bleeding index will be measured at six points around each implant by an index with a minimum value of 0 and a maximum of 3.
Time frame
Postoperative 6th month after implant placement and 12th month after prosthetic loadingSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov