Application of Sticky Bone and Bio-Oss Collagen in Alveolar Ridge Preservation

Not Applicable

Recruiting

• Conditions: Alveolar Bone Resorption

• Registration Number: NCT05902689
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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

Detailed 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

Study Timeline

• Study Start: 2023-05-31
• Status Verified: 2023-06
• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-15
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-23
• Primary Completion: 2024-02-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in horizontal ridge widths	baseline (before the surgery) and six months	Changes in horizontal ridge widths at 1, 3, and 5 mm below the ridge crest

Secondary Outcome Measures

Name	Time	Method
percentages of newly formed bone	six months	percentages of newly formed bone and residual bone substitute material in histologic sections
Thicknesses of the keratinized gingiva	baseline (before the surgery) and six months	Thicknesses of the keratinized gingiva at 2 and 4mm below the highest point of the gingiva
Changes in the vertical heights of the ridge	baseline (before the surgery) and six months	Changes in the vertical heights of the ridge at the buccal and lingual crest areas
width of the keratinized gingiva	baseline (before the surgery) and six months	width of the keratinized gingiva

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China