PeriodontitisNCT05188196
Efficacy of Collagen Sponge Versus Collagen Membrane on Ridge Preservation of Periodontally Compromised Teeth
A study testing alveolar ridge preservation in people with Periodontitis, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
The study aims to evaluate the efficacy of ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- alveolar ridge preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2022to 30 Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Need for molar extraction due to periodontal disease and plan for late implantation
- No acute infection, such as abscess or effusion
- Presence of bone defects on at one or two socket walls, where the height of the horizontal (suprabony) component of the defect (alveolar bone crest - cement-enamel junction) is >50% of the corresponding root length and the bone height of socket walls is at least 3 mm
- Presence of one adjacent tooth to the extraction site
Who cannot join
- Smoking
- Pregnancy or lactation
- Untreated periodontal disease
- Severe systemic conditions that contraindicate surgery (such as diabetes, heart disease, cancer etc.)
- Under radiotherapy
- Systemic disease or medication that influences bone metabolism and mucosal healing (such as immunosuppressants, phenytoin, bisphosphonates etc.)
- Extraction of multiple adjacent teeth
- Allergy to any of the materials used in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Peihui Ding, Doctor, 18957108518, phding@zju.edu.cn
About this study
Official title: Efficacy of Collagen Sponge Versus Collagen Membrane in Combination With Collagenated Bovine Bone Mineral on Ridge Preservation of Compromised Extraction Sockets in Periodontitis Patients: a Randomized Controlled Clinical Trial
The study aims to evaluate the efficacy of ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth.
Read the detailed description
The study aims to evaluate the changes of clinical and radiographic outcomes following ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth. The included patients will be randomized into two groups. The patients in control group will be treated with collagen membrane + collagenated bovine bone mineral, and those in the test group will be treated with collagen sponge + collagenated bovine bone mineral. The horizontal width of ridge, the vertical height of ridge at the buccal and palatal/lingual plates, width of keratinized tissue and thickness of mucosa will be measured before surgery and at 6 months postoperatively.
- Conditions
- Periodontitis
- Being tested
- alveolar ridge preservation
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar ridge preservationProcedure or surgery
Alveolar ridge preservation and augmentation commonly are performed immediately after tooth extraction to preserve or increase ridge volume within or beyond the skeletal envelope that exists at the time of extraction.
| Study group | Role | What they receive |
|---|---|---|
| Collagen Membrane | Active comparator | ridge preservation with collagen membrane + collagenated bovine bone mineral Receives: Procedure: alveolar ridge preservation |
| Collagen Sponge | Experimental | ridge preservation with collagen sponge + collagenated bovine bone mineral Receives: Procedure: alveolar ridge preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline horizontal width of ridge at 6 months
horizontal width of ridge at 1, 3, 5mm below crest
Measured: baseline, at 6 months
change from baseline vertical height of ridge at 6 months
vertical height of ridge at the buccal and palatal/lingual plates
Measured: baseline, at 6 months
Secondary outcomes (3)
width of keratinized tissue
measured from the MGJ to the mucosa margin at the mid-buccal aspect using a periodontal probe
Measured: at 6 months
thickness of mucosa
measured at the mid-buccal aspect using an endodontic file with a rubber stop
Measured: at 6 months
postoperative pain
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Measured: at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start30 Apr 2022
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peihui Ding, The Dental Hospital of Zhejiang University School of Medicine
- Investigators
- Peihui Ding, Doctor, Principal investigator, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188196
- Sponsor's protocol ID
- DHZhejiangU-2021（77）
- Status last verified
- Aug 2024
- First submitted
- 27 Dec 2021
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Collagen Sponge Versus Collagen Membrane in Combination With Collagenated Bovine Bone Mineral on Ridge Preservation of Compromised Extraction Sockets in Periodontitis Patients: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05188196
- Acronym / sponsor ID
- DHZhejiangU-2021（77）
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 12 Jan 2022 (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.
The study aims to evaluate the efficacy of ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth.
Detailed description
The study aims to evaluate the changes of clinical and radiographic outcomes following ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth. The included patients will be randomized into two groups. The patients in control group will be treated with collagen membrane + collagenated bovine bone mineral, and those in the test group will be treated with collagen sponge + collagenated bovine bone mineral. The horizontal width of ridge, the vertical height of ridge at the buccal and palatal/lingual plates, width of keratinized tissue and thickness of mucosa will be measured before surgery and at 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen Membrane | Active comparator | Procedure: alveolar ridge preservationridge preservation with collagen membrane + collagenated bovine bone mineral |
| Collagen Sponge | Experimental | Procedure: alveolar ridge preservationridge preservation with collagen sponge + collagenated bovine bone mineral |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Need for molar extraction due to periodontal disease and plan for late implantation
- No acute infection, such as abscess or effusion
- Presence of bone defects on at one or two socket walls, where the height of the horizontal (suprabony) component of the defect (alveolar bone crest - cement-enamel junction) is >50% of the corresponding root length and the bone height of socket walls is at least 3 mm
- Presence of one adjacent tooth to the extraction site
Key exclusion criteria (8 listed)
- Smoking
- Pregnancy or lactation
- Untreated periodontal disease
- Severe systemic conditions that contraindicate surgery (such as diabetes, heart disease, cancer etc.)
- Under radiotherapy
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 preservationAlveolar ridge preservation and augmentation commonly are performed immediately after tooth extraction to preserve or increase ridge volume within or beyond the skeletal envelope that exists at the time of extraction. | Procedure or surgery | Collagen Membrane, Collagen Sponge |
Primary outcome
change from baseline horizontal width of ridge at 6 months
Time frame: baseline, at 6 months
horizontal width of ridge at 1, 3, 5mm below crest
change from baseline vertical height of ridge at 6 months
Time frame: baseline, at 6 months
vertical height of ridge at the buccal and palatal/lingual plates
3 secondary outcomes
width of keratinized tissue
Time frame: at 6 months
thickness of mucosa
Time frame: at 6 months
postoperative pain
Time frame: at 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Peihui Ding, Doctor principal investigator
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
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 in people with Periodontitis, run by The Dental Hospital of 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 8 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: status not confirmed, as of the sponsor's last update on 7 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weida Li, master (0571-87219287, kyb@zjkq.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline horizontal width of ridge at 6 months (time frame: baseline, at 6 months). The study lists 2 primary outcomes in all. 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 7 Aug 2024.