Guided Tissue RegenerationNCT05789914
The Efficacy of Guided Tissue Regeneration With Extracellular Matrix Scaffold of Small Intestinal Submucosa (SIS) Membrane: a Randomized Controlled Clinical Trial
A study testing Flap surgery+bone graft+guided tissue regeneration in people with Guided Tissue Regeneration and Extracellular Matrix Scaffold of Small Intestinal Submucosa, run by Peking University at 1 site in China.
Trial summary
The most commonly used barrier membrane material in guided tissue regeneration is absorbable collagen membrane. Although the collagen membrane has a good barrier effect, it lacks the growth factors needed for periodontal tissue regeneration, which affects the effect of collagen membrane on periodontal tissue… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Guided Tissue Regeneration, Extracellular Matrix Scaffold of Small Intestinal Submucosa
- What is being tested?
- Flap surgery+bone graft+guided tissue regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2023to 1 Jan 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- periodontitis patients with stage III to IV, grade C had one or more intrabony defects with a depth of ≥3 mm; PD≥5mm after initial periodontal therapy.
Who cannot join
- smokers, pregnant female, other systematic disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Hospital of stomatology
Beijing, Beijing Municipality
Guojing Liu, +86 01082195368
About this study
Official title: Peking University School of Stomatology
The most commonly used barrier membrane material in guided tissue regeneration is absorbable collagen membrane. Although the collagen membrane has a good barrier effect, it lacks the growth factors needed for periodontal tissue regeneration, which affects the effect of collagen membrane on periodontal tissue regeneration. Extracellular Matrix Scaffold of Small Intestinal Submucosa (SIS) Membrane is a novel absorbable membrane that retains the extracellular matrix structure and is conducive to vascular ingrowth and tissue repair. The in vitro study showed that SIS membrane had excellent biocompatibility and certain antibacterial effect. Preclinical study also showed that SIS membrane significantly promoted the differentiation of bone marrow mesenchymal stem cells into osteoblasts, and promoted bone regeneration more effectively than collagen mechanism materials. SIS membrane can be used in soft tissue wound repair, guided bone regeneration, site preservation and other surgeries, and has achieved good therapeutic effects. However, whether the application of SIS membrane can achieve good therapeutic effect on periodontal guide tissue regeneration is still unclear. Therefore, in this study, the effects of guide tissue regeneration with collagen membrane and SIS membrane were compared through a randomized controlled clinical study.
- Being tested
- Flap surgery+bone graft+guided tissue regeneration
- Keywords
- guided tissue regeneration, Small Intestinal Submucosa, Randomized Controlled Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flap surgery+bone graft+guided tissue regenerationProcedure or surgery
after flap elevation and debridement, intrabony defect was filled with Bio-Oss and covered with membrane.
| Study group | Role | What they receive |
|---|---|---|
| Small Intestinal Submucosa Membrane | Experimental | Not described Receives: Procedure: Flap surgery+bone graft+guided tissue regeneration |
| Bio-guide | Active comparator | Not described Receives: Procedure: Flap surgery+bone graft+guided tissue regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical attachment loss
before and 6 months after surgery, examine the changes of CAL
Measured: Baseline and 6 months after surgery
clinical attachment loss
before and 12 months after surgery, examine the changes of CAL
Measured: baseline and 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start28 Mar 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guided Tissue RegenerationStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789914
- Sponsor's protocol ID
- PKUSSIRB-202384005
- Status last verified
- May 2024
- First submitted
- 1 Mar 2023
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peking University School of Stomatology
- ClinicalTrials.gov ID
- NCT05789914
- Acronym / sponsor ID
- PKUSSIRB-202384005
- Keywords
- guided tissue regeneration, Small Intestinal Submucosa, Randomized Controlled Clinical Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 29 Mar 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.
The most commonly used barrier membrane material in guided tissue regeneration is absorbable collagen membrane. Although the collagen membrane has a good barrier effect, it lacks the growth factors needed for periodontal tissue regeneration, which affects the effect of collagen membrane on periodontal tissue regeneration. Extracellular Matrix Scaffold of Small Intestinal Submucosa (SIS) Membrane is a novel absorbable membrane that retains the extracellular matrix structure and is conducive to vascular ingrowth and tissue repair. The in vitro study showed that SIS membrane had excellent biocompatibility and certain antibacterial effect. Preclinical study also showed that SIS membrane significantly promoted the differentiation of bone marrow mesenchymal stem cells into osteoblasts, and promoted bone regeneration more effectively than collagen mechanism materials. SIS membrane can be used in soft tissue wound repair, guided bone regeneration, site preservation and other surgeries, and has achieved good therapeutic effects. However, whether the application of SIS membrane can achieve good therapeutic effect on periodontal guide tissue regeneration is still unclear. Therefore, in this study, the effects of guide tissue regeneration with collagen membrane and SIS membrane were compared through a randomized controlled clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small Intestinal Submucosa Membrane | Experimental | Procedure: Flap surgery+bone graft+guided tissue regeneration |
| Bio-guide | Active comparator | Procedure: Flap surgery+bone graft+guided tissue regeneration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- periodontitis patients with stage III to IV, grade C had one or more intrabony defects with a depth of ≥3 mm; PD≥5mm after initial periodontal therapy.
Key exclusion criteria (1 listed)
- smokers, pregnant female, other systematic 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 |
|---|---|---|
| Flap surgery+bone graft+guided tissue regenerationafter flap elevation and debridement, intrabony defect was filled with Bio-Oss and covered with membrane. | Procedure or surgery | Bio-guide, Small Intestinal Submucosa Membrane |
Primary outcome
clinical attachment loss
Time frame: Baseline and 6 months after surgery
before and 6 months after surgery, examine the changes of CAL
clinical attachment loss
Time frame: baseline and 12 months after surgery.
before and 12 months after surgery, examine the changes of CAL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flap surgery+bone graft+guided tissue regeneration in people with Guided Tissue Regeneration and Extracellular Matrix Scaffold of Small Intestinal Submucosa, run by Peking University 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 1 inclusion and 1 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 10 May 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 Xiaowei Jia (+8601082195759, keyanchuethics@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical attachment loss (time frame: Baseline and 6 months after surgery). 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 10 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.