A Randomized Controlled Trial Evaluating Dental Implant Placement in the Anterior Esthetic Zone Using Two Guided Bone Regeneration Techniques: Prefabricated CAD/CAM Zirconia Membrane vs. Contour Augmentation.

NCT ID: NCT06987149

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-07-31

Brief Summary

This clinical trial aims to compare two guided bone regeneration (GBR) techniques in patients with horizontal ridge deficiency in the anterior esthetic region. Specifically, it evaluates the use of a prefabricated CAD/CAM zirconia membrane versus conventional contour augmentation performed simultaneously with dental implant placement. The study includes male and female patients aged 20 to 50 years who are in good general health, maintain adequate oral hygiene, and present with a Class I ridge defect as per Seibert's classification.

The primary objective is to determine whether the customized zirconia membrane provides equivalent clinical and radiographic outcomes in terms of bone gain and soft tissue healing compared to the contour augmentation technique. Participants will also report their postoperative discomfort and overall satisfaction using a 100-point visual analog scale (VAS), recorded at multiple time points: 1, 6, and 12 hours, as well as 1, 3, 7, and 15 days postoperatively.

Conditions

Alveolar Ridge Augmentation, Dental Implants; Alveolar Ridge Deficiency in the Anterior Esthetic Zone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CAD/CAM Zirconia Membrane Group

Participants in this group will undergo guided bone regeneration using a customized, prefabricated CAD/CAM zirconia membrane designed based on the individual's ridge defect morphology. This membrane will be used in combination with particulate bone graft material and placed simultaneously with the dental implant in the anterior maxilla.

Group Type: EXPERIMENTAL

CAD/CAM Zirconia Membrane

Intervention Type: DEVICE

A prefabricated, non-resorbable zirconia membrane fabricated using CAD/CAM technology for guided bone regeneration in horizontal ridge deficiencies during simultaneous dental implant placement.

Contour Augmentation Group

Participants in this group will undergo conventional guided bone regeneration using particulate bone graft material covered with a resorbable collagen membrane. The grafting procedure will be performed simultaneously with dental implant placement in the anterior maxilla.

Group Type: ACTIVE_COMPARATOR

Contour Augmentation

Intervention Type: PROCEDURE

Traditional guided bone regeneration using particulate bone graft and a resorbable collagen membrane, placed concurrently with the dental implant to augment horizontal ridge deficiencies.

Interventions

CAD/CAM Zirconia Membrane

A prefabricated, non-resorbable zirconia membrane fabricated using CAD/CAM technology for guided bone regeneration in horizontal ridge deficiencies during simultaneous dental implant placement.

Intervention Type: DEVICE

Contour Augmentation

Traditional guided bone regeneration using particulate bone graft and a resorbable collagen membrane, placed concurrently with the dental implant to augment horizontal ridge deficiencies.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients of both genders within the age range of 20-50 years.
• Patients with good general health and adequate oral hygiene practices.
• Stable periodontal condition and favorable soft tissue profile.
• Alveolar ridge that has a Class I defect according to Seibert's classification of ridge defects.

Exclusion Criteria

• Patients with medical conditions or systemic diseases precluding periodontal surgery or hampering wound healing (e.g., uncontrolled diabetes mellitus or metabolic bone disorders).
• Patients subjected to irradiation in the head and neck area.
• Patients with a history of taking any medications in the previous 6 months that may interfere with periodontal tissue health or healing.
• Patients have poor oral hygiene and motivation.
• Patients with active periodontitis or acute infection in the area intended for implant placement.
• Females who are pregnant or trying to conceive, and nursing mothers.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mohammed Mashhout Eisa Anas

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Mashhout Eisa Anas

Dentist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of dentistry- Tanta university

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

OMPDR 5-23 2

Identifier Type: -

Identifier Source: org_study_id