Guided Bone Regeneration in Lower Posterior Edentulous Arch Using Resorbable or Non Resorbable Membrane.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeirut Arab University
About this trial
the purpose of this study is to compare the efficiency of non-resorbable membrane versus resorbable membrane in guided bone regeneration in atrophic posterior mandible.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Mandibular posterior atrophic alveolar ridge Required horizontal bone augmentation procedures prior to implant placement.
Alveolar bone height suitable for implant placement.
Free of any local or systemic condition that may contraindicate ridge expansion procedure
The capacity to understand and accept the conditions of the study.
Disqualifiers
Heavy smokers (i.e., 2 or more packs of cigarettes per day);
Insufficient oral hygiene
Acute local or systemic infection
Patients with any systemic disease that may affect bone healing;
Trial design
Design model
Parallel
Treatments tested in this trial
guided bone regeneration using Resorbable membrane pericardium
Procedure/SurgeryA resorbable pericardium membrane will be fixed with titanium pins on the lingual bone plate (2-3mm from the bone crest) and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft). Overfilling of the graft will be respected to compensate for future resorption. The membrane will be stretched over the graft ensuring maximum immobilization of the graft.
guided bone regeneration using non resorbable ptfe membrane
Procedure/SurgeryA non-resorbable polytetrafluoroethylene (PTFE) membrane will be fixed with titanium tacks on the lingual bone plate (2-3mm from the bone crest) and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft). Overfilling of the graft will be respected to compensate for future resorption.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: guided bone regeneration using Resorbable membrane pericardiumExperimental treatment 1 intervention
Group B: guided bone regeneration using non resorbable membrane polytetrafluoroethylene PTFEExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Osstell Implant Stability Quotient (ISQ)
measure the implant stability in both group using osstell machine ,The ISQ scale ranges from 1 to 99, with higher values indicating greater stability
Time frame
6 months after the surgery at the time of implant placement2
change from baseline in pain as measured by the visual analogue scale VAS
pain sensation measured by VAS visual analogue scale score of both group the VAS ranges from 0 to 100 with 0 indicating no pain and higher scores indicating greater pain. scores are measured on a 100 mm VAS
Time frame
baseline,12 weeksSecondary outcomes
1
Horizontal bone gain measured using CBCT in mm
Participants will undergo radiographic evaluation using cone-beam computed tomography (CBCT) performed preoperatively, immediately post-operatively, and six months post-operatively. Linear horizontal ridge width will be measured at standardized reference points on the CBCT scans using digital caliper measurement tools within the CBCT analysis software. The outcome will assess the amount of horizontal bone gain (in millimeters) achieved following the augmentation procedure.
Time frame
6 months2
Qualitative bone assessment using histological and histomorphometric analysis to measure the % of bone
A core biopsy will be obtained from the grafted site six months post-operatively to evaluate the quality of regenerated bone. The specimen will undergo histological and histomorphometric analysis using standard light microscopy
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov