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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05902689
Collaborator
(none)
30
1
3
11.6
2.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: alveolar ridge preservation with bio-oss collagen
  • Procedure: alveolar ridge preservation with sticky bone
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The control group underwent natural healing, and the experimental group underwent alveolar ridge preservation using Bio-Oss Collagen and Sticky Bone, respectively.The control group underwent natural healing, and the experimental group underwent alveolar ridge preservation using Bio-Oss Collagen and Sticky Bone, respectively.
Masking:
Single (Participant)
Masking Description:
Only the investigator knew about the grouping, and the subjects did not know whether they were an experimental or control group or blank group.
Primary Purpose:
Treatment
Official Title:
Application of Sticky Bone and Bio-Oss Collagen in Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
Anticipated Study Start Date :
Jun 15, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: blank group

After non-traumatic tooth extraction, the control group will undergo natural healing.

Active Comparator: control group

After non-traumatic tooth extraction, the control 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: experimental group

After non-traumatic tooth extraction, the experimental 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. width of the keratinized gingiva [baseline (before the surgery) and six months]

    width of the keratinized gingiva

  4. percentages of newly formed bone [six months]

    percentages of newly formed bone and residual bone substitute material in histologic sections

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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%)

Contacts and Locations

Locations

Site City State Country Postal Code
1 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang China

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05902689
Other Study ID Numbers:
  • 2023-0369
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jun 1, 2023
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
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2023