NCT07679451

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Jan 2026Feb 2027

Study Start

First participant enrolled

January 1, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 25, 2026

Last Update Submit

June 25, 2026

Conditions

Alveolar Ridge Deficiency

Keywords

Guided Bone RegenerationPEEK membranePTFE membraneRidge augmentationMaxillary ridge augmentation

Outcome Measures

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.

    6 months after surgery

Study Arms (2)

PEEK Membrane Group

EXPERIMENTAL

Participants undergo maxillary alveolar ridge augmentation using a customized perforated polyether ether ketone (PEEK) membrane in combination with particulate bone graft material prior to implant placement.

Device: Custom-made PEEK Membrane

PTFE Membrane Group

EXPERIMENTAL

Participants undergo maxillary alveolar ridge augmentation using a polytetrafluoroethylene (PTFE) membrane in combination with particulate bone graft material prior to implant placement.

Device: PTFE Membrane

Interventions

Custom-made PEEK MembraneDEVICE

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

PEEK Membrane Group
PTFE MembraneDEVICE

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

PTFE Membrane Group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dania Raad

Al Mansurah, Dakhaliya, 12345, Egypt

RECRUITING

Central Study Contacts

Dania Raad, BDS

CONTACT

00201063498933raaddania7@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study is assessor-blinded. Clinical and surgical personnel are aware of treatment allocation due to the nature of the intervention. Radiographic outcomes (CBCT measurements of volumetric, horizontal, and vertical bone gain) will be evaluated by an independent assessor blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized into two separate groups: Group A: PEEK membrane Group B: PTFE membrane Each participant receives only one intervention throughout the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Up on request from the corresponding author

Locations

EG(1)