Clinical trial NCT06987149: 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.
Official title: Prefabricated CAD/CAM Zirconia Membrane Versus Contour Augmentation Simultaneously With Dental Implant Placement in the Anterior Esthetic Area.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Alveolar bone gain in millimetres (mm) in the edentulous alveolar ridge
timeFrame: Six months
Secondary outcomes:
measure: Periodontal Soft Tissue Healing (Modified Wound Healing Index - MWHI)
timeFrame: Baseline (day of surgery), and postoperatively at 4, 8, 12, and 24 weeks
measure: Patient-Reported Postoperative Discomfort and Satisfaction
timeFrame: 1 hour, 6 hours, 12 hours, and 1, 3, 7, 15 days postoperatively
measure: Membrane-Related Operative Time
timeFrame: Recorded during the implant placement and bone regeneration surgery
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of dentistry- Tanta university
state: Gharbia
Study officials:
References: