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NCT07851129
Evaluation of Bone Regeneration Outcomes Following Guided Bone Regeneration in the Anterior Maxillary Region
Conditions: Implant Placement in Maxillary Esthetic Zone
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Enrollment: 40
Sponsor: Fuming He
Location: The Affiliated Stomatology Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang
Summary
1. Research background: Guided bone regeneration (GBR), as a bone augmentation technique, is widely used for reconstructing hard tissue defects in implant placement in the anterior esthetic zone. According to the initial bone defect morphology and soft tissue morphology (e.g., the "gingival biotype") in the maxillary anterior esthetic zone, the clinical outcomes of bone regeneration after implantation can be improved by adjusting the direction of implant placement. Currently, few published studies have investigated the effects of bone defect morphology and gingival biotype on GBR outcomes; sample sizes and comprehensive analyses are insufficient, and some results are contradictory.
2. Research objective: Exploring the key soft-tissue factors influencing the osteogenic outcomes of guided bone regeneration in the maxillary anterior region. This study takes gingival biotype as the primary research factor and conducts a prospective cohort comparison between two groups, contrasting the effects of thin versus thick gingival biotypes on bone stability or resorption rates following GBR in the maxillary anterior area.
3. Study design and methods: Design type: prospective clinical study. Study duration: 3 years. Start time: From the date of adoption of ethics. End time: 2027. For all included patients, cone beam computed tomography (CBCT) scans and intraoral scans will be performed preoperatively, immediately postoperatively, and at 6 months postoperatively.
Eligibility Criteria
Inclusion Criteria:
1. Aged 18 years or older
2. A single tooth in the maxillary anterior region is to be implanted and restored with a single crown
3. A single implant-supported prosthesis in the maxillary anterior region
4. Severe bone deficiency in the maxillary anterior region, with residual alveolar bone height of 4-6 mm
5. The patient requests an implant-supported fixed prosthesis
6. The patient is able to understand and actively cooperate with the diagnostic and treatment process, and has signed the informed consent form
7. Good oral hygiene status
Exclusion Criteria:
1. Patients who cannot tolerate implant surgery (due to systemic diseases such as heart disease, hypertension, etc., or a history of long-term medication use)
2. Pregnancy or gestation
3. Daily smoking of more than 10 cigarettes
4. Presence of physical defects that may affect implant surgery
5. Patients with immune deficiency, including HIV-infected patients
6. Local inflammation, including untreated periodontitis
7. History of radiotherapy or chemotherapy to the head and neck region within the past year, or a history of intravenous bisphosphonate use
8. Severe bruxism or clenching habits
9. Poor oral hygiene or poor compliance
10. Patients who have previously undergone bone augmentation or soft-tissue augmentation at the implant site
11. Presence of benign or malignant tumors in the implant area
12. Bone defects such as severe osteoporosis
Source: ClinicalTrials.gov (NCT07851129). StuddyBuddy aggregates publicly available trial information.