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. (RCT)

Mohammed Mashhout Eisa Anas

Status: Active, not recruiting

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

Treatments: Device: CAD/CAM Zirconia Membrane; Procedure: Contour Augmentation

Study type: Interventional

Funder types: Other

Identifiers

NCT06987149

OMPDR 5-23 2

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

CAD/CAM Zirconia Membrane Group

Experimental group

Description:

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.

Treatment:

Device: CAD/CAM Zirconia Membrane

Contour Augmentation Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Contour Augmentation