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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-45
SponsorMansoura University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Custom-made PEEK Membrane

    Device

    Customized perforated polyether ether ketone (PEEK) membrane designed from preoperative CBCT data and used for guided bone regeneration during maxillary alveolar ridge augmentation.

  • PTFE Membrane

    Device

    Polytetrafluoroethylene (PTFE) membrane used for guided bone regeneration during maxillary alveolar ridge augmentation.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: PEEK Membrane GroupExperimental treatment 1 intervention
Group B: PTFE Membrane GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Volumetric Bone Gain

Volumetric bone gain in the augmented maxillary alveolar ridge measured using cone beam computed tomography (CBCT) and three-dimensional reconstruction software. Volumetric analysis will be performed by comparing immediate postoperative and 6-month postoperative CBCT scans. Volumetric bone gain in the augmented maxillary alveolar ridge measured using cone beam computed tomography (CBCT) and three-dimensional reconstruction software. Volumetric analysis will be performed by comparing immediate postoperative and 6-month postoperative CBCT scans.

Time frame
6 months after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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