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

Primary Purpose

Alveolar Bone Resorption

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
alveolar ridge preservation with bio-oss collagen
alveolar ridge preservation with sticky bone
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Resorption focused on measuring alveolar ridge preservation, Bio-OSS Collagen, sticky bone

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: The presence of one adjacent tooth at the extraction site Adequate oral hygiene (plaque index <20%;bleeding on probing <25% ) Need for tooth extraction due to endodontic,periapical or periodontal disease. Presence of ≥ 2 mm of keratinized tissue the extraction sockets have no more than 50% of buccal alveolar bone loss(Integrity of alveolar bone walls) Exclusion Criteria: Pregnancy or lactation Smoking more than 10 cigarettes per day with no evidence of acute infection such as severe swelling, suppuration at the extraction site Uncontrolled periodontal disease Existence of bone metabolic disease history of malignancy, radiotherapy, or chemotherapy in the past 5 years Administration of bisphosphonates long-term use of NSAIDs Alcohol or drug abuse Infectious disease, such as hepatitis or human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome (AIDS) Uncontrolled severe diabetes.( hemoglobin A1c >6.7%)

Sites / Locations

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

blank group

control group

experimental group

Arm Description

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

After non-traumatic tooth extraction, the control group will use alveolar ridge preservation with bio-oss collagen

After non-traumatic tooth extraction, the experimental group will use Sticky Bone for alveolar ridge preservation

Outcomes

Primary Outcome Measures

Changes in horizontal ridge widths
Changes in horizontal ridge widths at 1, 3, and 5 mm below the ridge crest

Secondary Outcome Measures

Changes in the vertical heights of the ridge
Changes in the vertical heights of the ridge at the buccal and lingual crest areas
Thicknesses of the keratinized gingiva
Thicknesses of the keratinized gingiva at 2 and 4mm below the highest point of the gingiva
width of the keratinized gingiva
width of the keratinized gingiva
percentages of newly formed bone
percentages of newly formed bone and residual bone substitute material in histologic sections

Full Information

First Posted
June 1, 2023
Last Updated
August 22, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05902689
Brief Title
Application of Sticky Bone and Bio-Oss Collagen in Alveolar Ridge Preservation
Official Title
Application of Sticky Bone and Bio-Oss Collagen in Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Resorption
Keywords
alveolar ridge preservation, Bio-OSS Collagen, sticky bone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The control group underwent natural healing, and the experimental group underwent alveolar ridge preservation using Bio-Oss Collagen and Sticky Bone, respectively.
Masking
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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
blank group
Arm Type
No Intervention
Arm Description
After non-traumatic tooth extraction, the control group will undergo natural healing.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
After non-traumatic tooth extraction, the control group will use alveolar ridge preservation with bio-oss collagen
Arm Title
experimental group
Arm Type
Experimental
Arm Description
After non-traumatic tooth extraction, the experimental group will use Sticky Bone for alveolar ridge preservation
Intervention Type
Procedure
Intervention Name(s)
alveolar ridge preservation with bio-oss collagen
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
alveolar ridge preservation with sticky bone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in horizontal ridge widths
Description
Changes in horizontal ridge widths at 1, 3, and 5 mm below the ridge crest
Time Frame
baseline (before the surgery) and six months
Secondary Outcome Measure Information:
Title
Changes in the vertical heights of the ridge
Description
Changes in the vertical heights of the ridge at the buccal and lingual crest areas
Time Frame
baseline (before the surgery) and six months
Title
Thicknesses of the keratinized gingiva
Description
Thicknesses of the keratinized gingiva at 2 and 4mm below the highest point of the gingiva
Time Frame
baseline (before the surgery) and six months
Title
width of the keratinized gingiva
Description
width of the keratinized gingiva
Time Frame
baseline (before the surgery) and six months
Title
percentages of newly formed bone
Description
percentages of newly formed bone and residual bone substitute material in histologic sections
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The presence of one adjacent tooth at the extraction site Adequate oral hygiene (plaque index <20%;bleeding on probing <25% ) Need for tooth extraction due to endodontic,periapical or periodontal disease. Presence of ≥ 2 mm of keratinized tissue the extraction sockets have no more than 50% of buccal alveolar bone loss(Integrity of alveolar bone walls) Exclusion Criteria: Pregnancy or lactation Smoking more than 10 cigarettes per day with no evidence of acute infection such as severe swelling, suppuration at the extraction site Uncontrolled periodontal disease Existence of bone metabolic disease history of malignancy, radiotherapy, or chemotherapy in the past 5 years Administration of bisphosphonates long-term use of NSAIDs Alcohol or drug abuse Infectious disease, such as hepatitis or human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome (AIDS) Uncontrolled severe diabetes.( hemoglobin A1c >6.7%)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Li Zhou, doctor
Phone
18329193003
Email
sophiazhou04@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Li Zhou, doctor
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Study Director
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Li Zhou, doctor
Phone
18329193003
Email
sophiazhou04@163.com

12. IPD Sharing Statement

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

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