Alveolar Bone Resorption Clinical Trial
Official title:
Application of Sticky Bone and Bio-Oss Collagen in Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
NCT number | NCT05902689 |
Other study ID # | 2023-0369 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 31, 2023 |
Est. completion date | June 1, 2024 |
In this experiment, after non-traumatic tooth extraction, the blank group underwent natural healing, and the control group underwent alveolar ridge preservation using Bio-Oss Collagen and the experimental group using Sticky Bone, to verify the application of Bio-Oss Collagen and Sticky Bone in alveolar ridge preservation
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 1, 2024 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. The presence of one adjacent tooth at the extraction site 2. Adequate oral hygiene (plaque index <20%;bleeding on probing <25% ) 3. Need for tooth extraction due to endodontic,periapical or periodontal disease. 4. Presence of = 2 mm of keratinized tissue 5. the extraction sockets have no more than 50% of buccal alveolar bone loss(Integrity of alveolar bone walls) Exclusion Criteria: 1. Pregnancy or lactation 2. Smoking more than 10 cigarettes per day 3. with no evidence of acute infection such as severe swelling, suppuration at the extraction site 4. Uncontrolled periodontal disease 5. Existence of bone metabolic disease 6. history of malignancy, radiotherapy, or chemotherapy in the past 5 years 7. Administration of bisphosphonates 8. long-term use of NSAIDs 9. Alcohol or drug abuse 10. Infectious disease, such as hepatitis or human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome (AIDS) 11. Uncontrolled severe diabetes.( hemoglobin A1c >6.7%) |
Country | Name | City | State |
---|---|---|---|
China | 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in horizontal ridge widths | Changes in horizontal ridge widths at 1, 3, and 5 mm below the ridge crest | baseline (before the surgery) and six months | |
Secondary | Changes in the vertical heights of the ridge | Changes in the vertical heights of the ridge at the buccal and lingual crest areas | baseline (before the surgery) and six months | |
Secondary | Thicknesses of the keratinized gingiva | Thicknesses of the keratinized gingiva at 2 and 4mm below the highest point of the gingiva | baseline (before the surgery) and six months | |
Secondary | width of the keratinized gingiva | width of the keratinized gingiva | baseline (before the surgery) and six months | |
Secondary | percentages of newly formed bone | percentages of newly formed bone and residual bone substitute material in histologic sections | six months |
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