Alveolar Bone ResorptionNCT05902689
Application of Sticky Bone and Bio-Oss Collagen in Alveolar Ridge Preservation
A study testing alveolar ridge preservation with bio-oss collagen and alveolar ridge preservation with sticky bone in people with Alveolar Bone Resorption, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption
- What is being tested?
- alveolar ridge preservation with bio-oss collagen and alveolar ridge preservation with sticky bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2023to 25 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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%)
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang
About this study
Official title: 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
Read the 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
- Conditions
- Alveolar Bone Resorption
- Being tested
- alveolar ridge preservation with bio-oss collagen, alveolar ridge preservation with sticky bone
- Keywords
- alveolar ridge preservation, Bio-OSS Collagen, sticky bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar ridge preservation with bio-oss collagenProcedure or surgery
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 boneProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: alveolar ridge preservation with sticky bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in horizontal ridge width
Changes in horizontal ridge widths at 3 mm below the ridge crest
Measured: baseline (before the surgery) and six months
Secondary outcomes (14)
Changes in horizontal ridge width
Changes in horizontal ridge widths at 1 mm below the ridge crest
Measured: baseline (before the surgery) and six months
Changes in horizontal ridge width
Changes in horizontal ridge widths at 5 mm below the ridge crest
Measured: baseline (before the surgery) and six months
Changes in the vertical heights of the ridge
Changes in the vertical heights of the ridge at the buccal and lingual crest areas
Measured: 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
Measured: baseline (before the surgery) and six months
width of the keratinized gingiva
width of the keratinized gingiva
Measured: 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
Measured: six months
The percentage of residual materials
Measured: six months postoperative
The bone density ratio
Measured: six months postoperative
The percentage of in alveolar bone volume within the region of interest (ROI) relative to the volume
Measured: at baseline
Postoperative response assessed by the Visual Analogue Scale (VAS) questionnaire
Measured: one week post-surgery
Changes in thickness of the peri-implant mucosa
Changes in buccolingual thickness of the peri-implant mucosa at 2 mm apical to the mucosal margin
Measured: at implant placement and one year after crown placement
Changes in marginal bone level
Changes in marginal bone level
Measured: at crown placement and one year after crown placement
Changes in peri-implant buccal bone thickness
Changes in peri-implant buccal bone thickness at 2 mm apical to the implant shoulder
Measured: at implant placement and one year after crown placement (T6).
Bleeding on probing and probing pocket depth
Bleeding on probing and probing pocket depth
Measured: one year after crown placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Jun 2023
- Primary completion15 Jan 2025
- Study completion25 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone ResorptionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Li Zhou, doctor, Study director, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902689
- Sponsor's protocol ID
- 2023-0369
- Status last verified
- Oct 2026
- First submitted
- 1 Jun 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Sticky Bone and Bio-Oss Collagen in Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05902689
- Acronym / sponsor ID
- 2023-0369
- Conditions
- Alveolar Bone Resorption
- Keywords
- alveolar ridge preservation, Bio-OSS Collagen, sticky bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 25 Sep 2026 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The control group underwent natural healing, and the experimental group underwent alveolar ridge preservation using Bio-Oss Collagen and Sticky Bone, respectively.
| Arm | Type | Receives |
|---|---|---|
| blank group | No intervention | –After non-traumatic tooth extraction, the control group will undergo natural healing. |
| Bio-Oss Collagen group | Experimental | Procedure: alveolar ridge preservation with bio-oss collagenAfter non-traumatic tooth extraction, the Bio-Oss Collagen group will use alveolar ridge preservation with bio-oss collagen |
| Sticky Bone group | Experimental | Procedure: alveolar ridge preservation with sticky boneAfter non-traumatic tooth extraction, the Sticky Bone group will use Sticky Bone for alveolar ridge preservation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alveolar ridge preservation with bio-oss collagenAlveolar 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. | Procedure or surgery | Bio-Oss Collagen group |
| alveolar ridge preservation with sticky boneAlveolar 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. | Procedure or surgery | Sticky Bone group |
Primary outcome
Changes in horizontal ridge width
Time frame: baseline (before the surgery) and six months
Changes in horizontal ridge widths at 3 mm below the ridge crest
14 secondary outcomes
Changes in horizontal ridge width
Time frame: baseline (before the surgery) and six months
Changes in horizontal ridge width
Time frame: baseline (before the surgery) and six months
Changes in the vertical heights of the ridge
Time frame: baseline (before the surgery) and six months
Thicknesses of the keratinized gingiva
Time frame: baseline (before the surgery) and six months
width of the keratinized gingiva
Time frame: baseline (before the surgery) and six months
percentages of newly formed bone
Time frame: six months
The percentage of residual materials
Time frame: six months postoperative
The bone density ratio
Time frame: six months postoperative
The percentage of in alveolar bone volume within the region of interest (ROI) relative to the volume
Time frame: at baseline
Postoperative response assessed by the Visual Analogue Scale (VAS) questionnaire
Time frame: one week post-surgery
Changes in thickness of the peri-implant mucosa
Time frame: at implant placement and one year after crown placement
Changes in marginal bone level
Time frame: at crown placement and one year after crown placement
Changes in peri-implant buccal bone thickness
Time frame: at implant placement and one year after crown placement (T6).
Bleeding on probing and probing pocket depth
Time frame: one year after crown placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Li Zhou, doctor study director
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alveolar ridge preservation with bio-oss collagen and alveolar ridge preservation with sticky bone in people with Alveolar Bone Resorption, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in horizontal ridge width (time frame: baseline (before the surgery) and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.