Gingival DiseasesNCT05389059
Injectable Platelet Rich Fibrin With Collagen Matrix in Treatment of Multiple Gingival Recession.
A study testing CAF+CM and I-PRF in people with Gingival Diseases and Traumatic Injury, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study is proposing the use of i-PRF clot as a scaffold for the XCM in order to obtain a novel biomaterial, incorporating active growth factors and collagen matrix in a single framework, based on the potential effect of i-PRF to enhance fibroblast activity and angiogenesis stimulation for treatment of multiple… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Diseases, Traumatic Injury
- What is being tested?
- CAF+CM and I-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIraq
- Study dates
- 25 Apr 2022to 1 Sep 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of at least two localized gingival recessions on either sides of the maxilla and/or mandible excluding molar region.
- The cemento-enamel junction (CEJ) is visible in the teeth for root coverage procedures.
- All recessions are type 1recession RT1 (cairo et al,2011) which correspond to Miller I\&II gingival recession
- All patients must demonstrate adequate plaque control with a fullmouth plaque score less than 20% and with .
- All patients at least 18 years of age and of both genders.
Who cannot join
- Smoker Patients .
- Patients with diabetes.
- Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy.
- pregnant or nursing women.
- Patients taking medications or having treatments with an effect on mucosal healing in general (e.g. steroids, large doses of antiinflammatory drugs).
- Patients with a disease affecting connective tissue metabolism.
- Patients allergic to collagen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Injectable Platelet Rich Fibrin With Volume Stable Collagen Matrix in Treatment of Multiple Gingival Recession; a Randomized Clinical Trial.
This study is proposing the use of i-PRF clot as a scaffold for the XCM in order to obtain a novel biomaterial, incorporating active growth factors and collagen matrix in a single framework, based on the potential effect of i-PRF to enhance fibroblast activity and angiogenesis stimulation for treatment of multiple gingival recession.
- Conditions
- Gingival Diseases, Traumatic Injury
- Being tested
- CAF+CM, I-PRF
- Keywords
- Gingival Recession, Collagen Matrix, Plasma rich proten
- Medical subject headings
- Gingival Diseases, Wounds and Injuries, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAF+CMProcedure or surgery
Periodontal surgery including CAF+CM application
I-PRFProcedure or surgery
Periodontal surgery including CAF+CM application with i-PRF
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Other | Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I\&II gingival recession. Receives: Procedure: CAF+CM |
| Experimental arm | Other | Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I\&II gingival recession. Receives: Procedure: CAF+CM; Procedure: I-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in gingival recession depth on the buccal sides of type one gingival recessionRT1
The primary outcome of the study is the reduction in gingival recession depth on the buccal sides of RT1 gingival recession, between the baseline preoperative measurement and follow-up at 3 months and 6 months. The Recession Depth (RD) is Measured in millimeter (mm) from CEJ (Cemento-Enamel-Junction) to the gingival margin using UNC-15 probe.
Measured: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Secondary outcomes (7)
Improvement in Gingival Thickness (GT)
Gingival Thickness (GT) is determined at 1.5 mm apical to the gingival margin using a caliper (endodontic reamer#20) rounded to the nearest 0.1mm.
Measured: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Improvement in the Keratinized Tissue Height (KTH)
Keratinized Tissue Height (KTH) is measured in millimeters (mm) taken at the mid buccal aspect of the involved teeth from the gingival margin to the muco-gingival junction, by a manual periodontal probe (UNC-15 probe,Hu-Friedy,Chicago,USA).
Measured: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Reduction in the Recession Width (RW)
Recession Width (RW) is measured in millimeter (mm) at the Cement-Enamel Junction (CEJ) using UNC-15 probe.
Measured: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Reduction in Probing Pocket Depth (PPD)
Probing Pocket Depth (PPD) is measured in millimeter (mm) from the gingival margin to the apical extend of the probe.
Measured: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Reduction Clinical Attachment Level (CAL)
Clinical Attachment Level (CAL) is measured in millimeter (mm) from the CEJ to the apical extend of the probe.
Measured: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Measuring Plaque-Index (PI)
Plaque-Index (PI) is measured as a percentage of the presence of Plaque on four surfaces of the teeth using a manual periodontal probe.
Measured: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Measuring Bleeding On Probing (BOP)
Bleeding On Probing (BOP) is measured as a percentage of sites with bleeding on probing using a manual periodontal probe.
Measured: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start25 Apr 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival DiseasesStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basima Ghaffoori Ali, University of Baghdad
- Investigators
- Basima Gh Ali, MSc, Principal investigator, University of BaghdadThair AL Hassan, PHD, Study director, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389059
- Sponsor's protocol ID
- 519622
- Status last verified
- May 2022
- First submitted
- 24 Apr 2022
- Last updated
- 24 May 2022
- 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 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Injectable Platelet Rich Fibrin With Volume Stable Collagen Matrix in Treatment of Multiple Gingival Recession; a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05389059
- Acronym / sponsor ID
- 519622
- Conditions
- Gingival Diseases, Traumatic Injury
- Keywords
- Gingival Recession, Collagen Matrix, Plasma rich proten
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 24 May 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.
This study is proposing the use of i-PRF clot as a scaffold for the XCM in order to obtain a novel biomaterial, incorporating active growth factors and collagen matrix in a single framework, based on the potential effect of i-PRF to enhance fibroblast activity and angiogenesis stimulation for treatment of multiple gingival recession.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Other | Procedure: CAF+CMPatients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I\&II gingival recession. |
| Experimental arm | Other | Procedure: CAF+CM, Procedure: I-PRFPatients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I\&II gingival recession. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Presence of at least two localized gingival recessions on either sides of the maxilla and/or mandible excluding molar region.
- The cemento-enamel junction (CEJ) is visible in the teeth for root coverage procedures.
- All recessions are type 1recession RT1 (cairo et al,2011) which correspond to Miller I\&II gingival recession
- All patients must demonstrate adequate plaque control with a fullmouth plaque score less than 20% and with .
- All patients at least 18 years of age and of both genders.
Key exclusion criteria (7 listed)
- Smoker Patients .
- Patients with diabetes.
- Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy.
- pregnant or nursing women.
- Patients taking medications or having treatments with an effect on mucosal healing in general (e.g. steroids, large doses of antiinflammatory drugs).
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 |
|---|---|---|
| CAF+CMPeriodontal surgery including CAF+CM application | Procedure or surgery | Control arm, Experimental arm |
| I-PRFPeriodontal surgery including CAF+CM application with i-PRF | Procedure or surgery | Experimental arm |
Primary outcome
Reduction in gingival recession depth on the buccal sides of type one gingival recessionRT1
Time frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
The primary outcome of the study is the reduction in gingival recession depth on the buccal sides of RT1 gingival recession, between the baseline preoperative measurement and follow-up at 3 months and 6 months. The Recession Depth (RD) is Measured in millimeter (mm) from CEJ (Cemento-Enamel-Junction) to the gingival margin using UNC-15 probe.
7 secondary outcomes
Improvement in Gingival Thickness (GT)
Time frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Improvement in the Keratinized Tissue Height (KTH)
Time frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Reduction in the Recession Width (RW)
Time frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Reduction in Probing Pocket Depth (PPD)
Time frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Reduction Clinical Attachment Level (CAL)
Time frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Measuring Plaque-Index (PI)
Time frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Measuring Bleeding On Probing (BOP)
Time frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- 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.
Basima Gh Ali, MSc principal investigator
University of Baghdad
Thair AL Hassan, PHD study director
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAF+CM and I-PRF in people with Gingival Diseases and Traumatic Injury, run by University of Baghdad at 1 site in Iraq.
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 7 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 24 May 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 Iraq. 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?
Reduction in gingival recession depth on the buccal sides of type one gingival recessionRT1 (time frame: Between the baseline preoperative measurement and follow-up at 3 months and 6 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 24 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.