Periodontal DiseasesNCT04851847
A Clinical Trial to Evaluate the Safety and Effectiveness of Resorbable Collagen Membrane - MatrixflexTM
A study testing Guided Tissue Regeneration (GTR) in people with Periodontal Diseases and Intrabony Defects, run by Collagen Matrix at 1 site in China.
Trial summary
This is a randomized, single blind, parallel-arm, multi-center, non-inferior clinical trial. 174 patients are recruited in total, and they are treated by Guided Tissue Regeneration (GTR). The patients are split in to two groups evenly: 87 in the experimental group and 87 in the control group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontal Diseases, Intrabony Defects, Guided Tissue Regeneration
- What is being tested?
- Guided Tissue Regeneration (GTR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2021to 1 Aug 2022
- 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
- Aged 18 to 65 years, male or female;
- patients were clinically diagnosed with chronic periodontitis according to the international classification of periodontal disease in 1999;
- Only solitary lesion site requires surgical treatment and must meet the following criteria:
- The baseline PD≥7 mm ;
- After debridement during operation, the defect of the vertical bone at the adjacent surface ≥4mm, and at least one alveolar buccal wall can be detected;
- The wideness of the keratinized gingiva≥2 mm;
- Based on the X-Ray image, the dental crowns at the bottom of the bone socket should be at least 3mm;
Who cannot join
- The test tooth has open surgical debridement history within the most recent one years;
- Known allergy to collagen of animal origin;
- Clinical or radiographic signs of untreated acute infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cemento-enamel projections not easily removed by odontoplasty, untreated carious lesions at the cemento-enamel junction (CEJ) or on the root surface, subgingival restorations and/or restorations with open margins at or below the CEJ;
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
About this study
Official title: A Clinical Trial to Evaluate the Safety and Effectiveness of Resorbable Collagen Membrane - MatrixflexTM for the Treatment of Periodontal Intrabony Defects
This is a randomized, single blind, parallel-arm, multi-center, non-inferior clinical trial. 174 patients are recruited in total, and they are treated by Guided Tissue Regeneration (GTR). The patients are split in to two groups evenly: 87 in the experimental group and 87 in the control group.
- Being tested
- Guided Tissue Regeneration (GTR)
- Keywords
- resorbable collagen membrane
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Tissue Regeneration (GTR)Device
Use of resorbable collagen membrane to treat periodontal intrabony defects.
| Study group | Role | What they receive |
|---|---|---|
| MatrixflexTM resorbable collagen membrane | Experimental | Experimental arm using the Matrixflex Resorbable Collagen Membrane for treatment of periodontal intrabony defects Receives: Device: Guided Tissue Regeneration (GTR) |
| control group membrane | Active comparator | Control arm using the Comparator Xenograft Resorbable Collagen Membrane or treatment of periodontal intrabony defects Receives: Device: Guided Tissue Regeneration (GTR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of CAL at 12 weeks after surgery
Assessment of clinical attachment level
Measured: 12 weeks
The change of CAL at 24 weeks after surgery
Assessment of clinical attachment level
Measured: 24 weeks
The change of PD at 12 weeks after surgery
Assessment of Probing Depth
Measured: 12 weeks
The change of PD at 24 weeks after surgery
Assessment of Probing Depth
Measured: 24 weeks
Secondary outcomes (2)
The ratio between Baseline and gingival recession (GR) at 12 weeks after surgery.
Effect on Gingival recession
Measured: 12 weeks
The ratio between Baseline and gingival recession (GR) at 24 weeks after surgery.
Effect on Gingival recession
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start10 Jun 2021
- Primary completion20 Jul 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collagen Matrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851847
- Sponsor's protocol ID
- D20190472-P
- Status last verified
- Mar 2022
- First submitted
- 14 Apr 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wang Y, Yan F, Chen L, Zhao L, Liu M, Ge S, Chen CY, Kim DM, Shu R. Crosslinked Versus Non-Crosslinked Resorbable Collagen Membranes for Periodontal Regeneration: A Multicenter, Randomized, Double-Blind, Non-Inferiority Clinical Trial. J Periodontal Res. 2025 Nov;60(11):1086-1100. doi: 10.1111/jre.13382. Epub 2025 Jan 12.
PubMed 39799466
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Safety and Effectiveness of Resorbable Collagen Membrane - MatrixflexTM for the Treatment of Periodontal Intrabony Defects
- ClinicalTrials.gov ID
- NCT04851847
- Acronym / sponsor ID
- D20190472-P
- Keywords
- resorbable collagen membrane
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Collagen MatrixIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 21 Apr 2021 (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.
This is a randomized, single blind, parallel-arm, multi-center, non-inferior clinical trial. 174 patients are recruited in total, and they are treated by Guided Tissue Regeneration (GTR). The patients are split in to two groups evenly: 87 in the experimental group and 87 in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MatrixflexTM resorbable collagen membrane | Experimental | Device: Guided Tissue Regeneration (GTR)Experimental arm using the Matrixflex Resorbable Collagen Membrane for treatment of periodontal intrabony defects |
| control group membrane | Active comparator | Device: Guided Tissue Regeneration (GTR)Control arm using the Comparator Xenograft Resorbable Collagen Membrane or treatment of periodontal intrabony defects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 to 65 years, male or female;
- patients were clinically diagnosed with chronic periodontitis according to the international classification of periodontal disease in 1999;
- Only solitary lesion site requires surgical treatment and must meet the following criteria:
Key exclusion criteria (3 listed)
- The test tooth has open surgical debridement history within the most recent one years;
- Known allergy to collagen of animal origin;
- Clinical or radiographic signs of untreated acute infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cemento-enamel projections not easily removed by odontoplasty, untreated carious lesions at the cemento-enamel junction (CEJ) or on the root surface, subgingival restorations and/or restorations with open margins at or below the CEJ;
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 |
|---|---|---|
| Guided Tissue Regeneration (GTR)Use of resorbable collagen membrane to treat periodontal intrabony defects. | Device | MatrixflexTM resorbable collagen membrane, control group membrane |
Primary outcome
The change of CAL at 12 weeks after surgery
Time frame: 12 weeks
Assessment of clinical attachment level
The change of CAL at 24 weeks after surgery
Time frame: 24 weeks
Assessment of clinical attachment level
The change of PD at 12 weeks after surgery
Time frame: 12 weeks
Assessment of Probing Depth
The change of PD at 24 weeks after surgery
Time frame: 24 weeks
Assessment of Probing Depth
2 secondary outcomes
The ratio between Baseline and gingival recession (GR) at 12 weeks after surgery.
Time frame: 12 weeks
The ratio between Baseline and gingival recession (GR) at 24 weeks after surgery.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Derived from this study: PubMed 39799466Wang Y, Yan F, Chen L, Zhao L, Liu M, Ge S, Chen CY, Kim DM, Shu R. Crosslinked Versus Non-Crosslinked Resorbable Collagen Membranes for Periodontal Regeneration: A Multicenter, Randomized, Double-Blind, Non-Inferiority Clinical Trial. J Periodontal Res. 2025 Nov;60(11):1086-1100. doi: 10.1111/jre.13382. Epub 2025 Jan 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Tissue Regeneration (GTR) in people with Periodontal Diseases and Intrabony Defects, run by Collagen Matrix 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 7 inclusion and 3 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 9 Mar 2022. 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?
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?
The change of CAL at 12 weeks after surgery (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04851847, which also lists 1 linked publication.
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 9 Mar 2022.