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.

NCT06987149 | Active Not Recruiting

• 1 other identifier: OMPDR 5-23 2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Alveolar ridge augmentation; Dental implant; Guided bone regeneration; Countour augmentation; Prefabricated CAD/CAM zirconia membrane; Alveolar ridge deficiency; Anterior Esthetic Zone

Outcome Measures

Primary Outcomes (1)

• Alveolar bone gain in millimetres (mm) in the edentulous alveolar ridge

  Assessment of the horizontal and vertical bone gain in millimetres (mm) in the edentulous alveolar ridge from baseline (implant placement and grafting) to six months after surgery.

  Six months

Secondary Outcomes (3)

• Periodontal Soft Tissue Healing (Modified Wound Healing Index - MWHI)

  Baseline (day of surgery), and postoperatively at 4, 8, 12, and 24 weeks

• Patient-Reported Postoperative Discomfort and Satisfaction

  1 hour, 6 hours, 12 hours, and 1, 3, 7, 15 days postoperatively

• Membrane-Related Operative Time

  Recorded during the implant placement and bone regeneration surgery

Study Arms (2)

CAD/CAM Zirconia Membrane Group

EXPERIMENTAL

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.

Device: CAD/CAM Zirconia Membrane

Contour Augmentation Group

ACTIVE COMPARATOR

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.

Procedure: Contour Augmentation

Interventions

CAD/CAM Zirconia Membrane 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.

CAD/CAM Zirconia Membrane Group

Contour Augmentation 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.

Contour Augmentation Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohammed Mashhout Eisa Anas: lead

Study Sites (1)

Faculty of dentistry- Tanta university

Tanta, Gharbia Governorate, 3111, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 23, 2025
• Study Start: November 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 23, 2025

Record last verified: 2024-05

Locations

EG (1)