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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2023
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Li Li Zhou, doctor
Phone 18329193003
Email sophiazhou04@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Within 6 months after tooth extraction, the remaining alveolar ridge undergoes varying degrees of absorption, resulting in a decrease in horizontal width and vertical height of the alveolar ridge. The three-dimensional size change of the alveolar socket may affect the implantation of later implants and cause aesthetic and functional problems. Alveolar ridge preservation can maintain the volume of the alveolar socket, prevent soft tissue from growing into undesirable positions, slow down the absorption of the alveolar ridge to some extent, promote new bone formation, and maintain the shape of the extraction socket. This is crucial for later implant treatment for missing teeth. 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, respectively, to verify the application of Bio-Oss Collagen and Sticky Bone in alveolar ridge preservation


Recruitment information / eligibility

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%)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
alveolar ridge preservation with bio-oss collagen
Alveolar ridge preservation with bio-oss collagen is a surgical method that reduces or limits the physiological resorption of alveolar bone after tooth extraction by implanting bio-oss collagen in the socket and covering the biological barrier membrane.
alveolar ridge preservation with sticky bone
Alveolar ridge preservation with sticky bone is a surgical method that reduces or limits the physiological resorption of alveolar bone after tooth extraction by implanting sticky bone in the socket and covering the biological barrier membrane.

Locations

Country Name City State
China 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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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