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

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

In this experiment, after non-traumatic tooth extraction, the blank group underwent natural healing, and the Bio-Oss Collagen underwent alveolar ridge preservation using Bio-Oss Collagen and the Sticky Bone group using Sticky Bone, to verify the application of Bio-Oss Collagen and Sticky Bone in alveolar ridge preservation

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Resorption
• Intervention / Treatment: Procedure: alveolar ridge preservation with bio-oss collagen; Procedure: alveolar ridge preservation with sticky bone

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 Bio-Oss Collagen group underwent alveolar ridge preservation using Bio-Oss Collagen and the Sticky Bone group using Sticky Bone, respectively, to verify the application of Bio-Oss Collagen and Sticky Bone in alveolar ridge preservation

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: blank group; After non-traumatic tooth extraction, the control group will undergo natural healing.
Experimental: Bio-Oss Collagen group; After non-traumatic tooth extraction, the Bio-Oss Collagen group will use alveolar ridge preservation with bio-oss collagen	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.
Experimental: Sticky Bone group; After non-traumatic tooth extraction, the Sticky Bone group will use Sticky Bone for alveolar ridge preservation	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
width of the keratinized gingiva	width of the keratinized gingiva	baseline (before the surgery) and six months
percentages of newly formed bone	percentages of newly formed bone and residual bone substitute material in histologic sections	six months
The percentage of residual materials		six months postoperative
The bone density ratio		six months postoperative
The percentage of in alveolar bone volume within the region of interest (ROI) relative to the volume		at baseline
Postoperative response assessed by the Visual Analogue Scale (VAS) questionnaire		one week post-surgery

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Li Li Zhou, doctor, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): August 15, 2025
• Study Completion (Actual): September 15, 2025

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: alveolar ridge preservation; sticky bone; Bio-OSS Collagen
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: 2023-0369

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes