Custom-Made PEEK Versus PTFE Membranes in Maxillary Alveolar Ridge Augmentation

Custom-Made Polyether Ether Ketone Membrane Versus Polytetrafluoroethylene Membrane in Maxillary Alveolar Ridge Augmentation: A Randomized Controlled Clinical Trial

This randomized controlled clinical study aims to evaluate and compare the effectiveness of custom-made polyether ether ketone (PEEK) membranes versus polytetrafluoroethylene (PTFE) membranes in guided bone regeneration for maxillary alveolar ridge augmentation in the esthetic zone. Thirty patients requiring ridge augmentation prior to dental implant placement will be enrolled and randomly allocated into two equal groups. Group A will receive customized PEEK membranes, while Group B will be treated with PTFE membranes. Clinical and radiographic assessments, including cone beam computed tomography (CBCT), will be performed immediately postoperatively, at 6 months, and at 12 months to evaluate volumetric, horizontal, and vertical bone gain as well as soft tissue healing and complication rates.

Guided bone regeneration (GBR) is a widely accepted technique used to reconstruct deficient alveolar ridges prior to or in conjunction with dental implant placement. This study is designed to evaluate the clinical and radiographic outcomes of two different non-resorbable barrier membranes in maxillary ridge augmentation: customized polyether ether ketone (PEEK) membranes and polytetrafluoroethylene (PTFE) membranes.

Thirty patients requiring maxillary alveolar ridge augmentation in the esthetic zone will be recruited from the Outpatient Clinic of the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University. Patients will be randomly allocated into two groups of equal size. Group A will receive patient-specific 3D-printed PEEK membranes designed using cone beam computed tomography (CBCT) data and computer-aided design/computer-aided manufacturing (CAD/CAM) technology. Group B will receive PTFE membranes stabilized over the grafted site using bone tacks.

In both groups, autogenous bone graft combined with xenogeneic bone substitute will be used for ridge augmentation. Standard surgical protocols will be followed, including flap elevation, recipient site preparation, graft placement, and tension-free primary closure.

Clinical outcomes will be assessed by evaluating soft tissue healing, infection, membrane exposure, and wound dehiscence. Radiographic outcomes will be evaluated using CBCT scans taken immediately postoperatively, at 6 months, and at 12 months. Three-dimensional analysis will be performed using specialized software to measure volumetric bone gain as well as linear horizontal and vertical ridge augmentation.

The study aims to determine whether customized PEEK membranes provide comparable or superior outcomes to PTFE membranes in terms of bone regeneration, stability of augmented volume, and postoperative complications.

Inclusion Criteria:

Age between 20 and 45 years. Male or female participants. Presence of single or multiple missing teeth associated with vertical alveolar defects (vertical bone height less than 8 mm), horizontal alveolar defects (ridge width less than 6 mm), or combined defects in the maxillary esthetic zone requiring alveolar ridge augmentation before implant placement.

Good oral hygiene.

Exclusion Criteria:

Uncontrolled medical disorders contraindicating surgical intervention. Systemic diseases or medications affecting bone metabolism. Current or previous bisphosphonate therapy. History of radiotherapy. History of chemotherapy. Smokers.