NCT05902689

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

April 13, 2026

Status Verified

March 1, 2025

Enrollment Period

2.2 years

First QC Date

June 1, 2023

Last Update Submit

April 7, 2026

Conditions

Keywords

alveolar ridge preservationBio-OSS Collagensticky bone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Changes in the vertical heights of the ridge

    baseline (before the surgery) and six months

  • Thicknesses of the keratinized gingiva

    baseline (before the surgery) and six months

  • width of the keratinized gingiva

    baseline (before the surgery) and six months

  • percentages of newly formed bone

    six months

  • The percentage of residual materials

    six months postoperative

  • +3 more secondary outcomes

Study Arms (3)

blank group

NO INTERVENTION

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

Bio-Oss Collagen group

EXPERIMENTAL

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

Sticky Bone group

EXPERIMENTAL

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

Procedure: alveolar ridge preservation with sticky bone

Interventions

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.

Sticky Bone group

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.

Bio-Oss Collagen group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, China

Location

Study Officials

  • Li Li Zhou, doctor

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The control group underwent natural healing, and the experimental group underwent alveolar ridge preservation using Bio-Oss Collagen and Sticky Bone, respectively.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 15, 2023

Study Start

June 15, 2023

Primary Completion

August 15, 2025

Study Completion

September 15, 2025

Last Updated

April 13, 2026

Record last verified: 2025-03

Locations