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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Periodontal Soft Tissue Healing (Modified Wound Healing Index - MWHI) | Evaluation of periodontal soft tissue healing around the surgical site using the Modified Wound Healing Index (MWHI) developed by Huang et al. This index categorizes wound healing based on clinical parameters including mucosal edema, erythema, graft exposure, and presence of suppuration. Scores range from 1 to 3: Score 1 - Uneventful Healing: No or minimal mucosal edema or erythema, with no suppuration or graft exposure. Score 2 - Normal Healing: Slight to moderate mucosal edema, erythema, and/or graft exposure, but without suppuration. Score 3 - Poor Healing: Significant mucosal edema, erythema, graft exposure, and presence of suppuration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry- Tanta university | Tanta | Gharbia Governorate | 3111 | Egypt |
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| 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. |
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| Baseline (day of surgery), and postoperatively at 4, 8, 12, and 24 weeks |
| Patient-Reported Postoperative Discomfort and Satisfaction | Assessment of postoperative discomfort and overall patient satisfaction using a 100-point Visual Analog Scale (VAS). Participants will self-report their pain levels and satisfaction at multiple postoperative time points: 1, 6, and 12 hours, as well as 1, 3, 7, and 15 days after surgery. | 1 hour, 6 hours, 12 hours, and 1, 3, 7, 15 days postoperatively |
| Membrane-Related Operative Time | Measurement of the time (in minutes) required to place the guided bone regeneration membrane during the surgical procedure. This will assess the efficiency and ease of use of the prefabricated CAD/CAM zirconia membrane compared to conventional contour augmentation. | Recorded during the implant placement and bone regeneration surgery |