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

Alveolar Bone Resorption Clinical Trial

Official title:

Application of Sticky Bone and Bio-Oss Collagen in Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902689
• Other study ID #: 2023-0369
• Status: Recruiting
• Phase: N/A
• 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
• 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%)

Related Conditions & MeSH terms

• Alveolar Bone Resorption
• Bone Resorption

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