A Randomized Controlled Trial Evaluating Dental Implant Placement in the Anterior Esthetic Zone U… (NCT06987149) | Clinical Trial Compass
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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.
Egypt20 participantsStarted 2024-11-01
Plain-language 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.
Who can participate
Age range
20 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Alveolar bone gain in millimetres (mm) in the edentulous alveolar ridge