Chronic PeriodontitisPhase 4NCT03419429
Simvastatin Gel With Perforated Resorbable Membranes in Treatment of Intrabony Defects in Chronic Periodontitis
A Phase 4 study testing Simvastatin, EDTA and Occlusive membrane in people with Chronic Periodontitis, run by Ain Shams University.
Trial summary
Modified perforated membrane (MPM) is considered as a modality that could enable participation of periosteal cells and gingival stem cells which could improve the outcomes of guided tissue regeneration more than the use of the traditional occlusive membrane (OM). Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Simvastatin, EDTA and Occlusive membrane
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2017
- Phase
- Phase 4
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients were all healthy and free from any systemic disease.
- No history of antibiotic therapy or periodontal treatment for at least six months preceding the study.
- Patients were willing and able to return for multiple follow up visits.
- Periodontal defects with
- Probing depth > 5 mm.
- Clinical attachment loss >4 mm.
- Standardized radiographic evidence of interproximal intrabony defect using periapical radiograph.
- Good level of oral hygiene (plaque and gingival indices score after initial phase therapy should be less than one).
Who cannot join
- Pregnancy, lactation for female patients.
- Smokers, alcoholics and those receiving any medication that could affect healing of soft tissue and bone as steroids and cyclosporines.
- History of allergic reaction to the medications used.
- Vulnerable groups and handicapped.
About this study
Official title: The Use of Simvastatin Gel With Perforated Resorbable Membranes in the Treatment of Intrabony Defects in Chronic Periodontitis Patients (Clinical and Biochemical Study)
Modified perforated membrane (MPM) is considered as a modality that could enable participation of periosteal cells and gingival stem cells which could improve the outcomes of guided tissue regeneration more than the use of the traditional occlusive membrane (OM). Simvastatin (SMV) modulates bone formation by increasing the expression of bone morphogenetic protein 2 and angiogenesis. Ethylenediaminetetraacitic acid (EDTA) found to be effective as low ph etchant for smear layer removal and exposing root surface collagen. The investigators compared the clinical and radiographic outcome of SMV gel combined with MPM to SMV gel combined with OM with and without an associated EDTA gel root surface etching for improving bone regeneration in intrabony defects in chronic periodontitis patients. Moreover, evaluation of SMV gingival crevicular fluid (GCF) levels availability for 30 days in cases with and without EDTA root surface etching was performed.
Read the detailed description
Forty patients with 40 intrabony defects having chronic periodontitis were randomly assigned into four equal groups to receive open flap procedure, 1.2% SMV gel and covering the defect with OM (Group I), open flap procedure, 1.2% SMV gel and covering the defect with MPM (Group II), open flap procedure, 24% EDTA root surface etching,1.2% SMV gel and then coverage of the defect by OM (Goup III), or open flap procedure, 24% EDTA root surface etching, 1.2% SMV gel and then coverage of the defect by MPM (Group IV). Plaque index, gingival index,probing pocket depth, clinical attachment level, defect base level, crestal bone level, and radiodensitometric measurements were measured at baseline and reassessed at 6 and 9 months after therapy. Additionally, GCF was collected from group I, II, III and IV at 1,7,14, 21, and 30 days in order to evaluate SMV availability and the effect of EDTA root surface etching on its availability using High-performance liquid chromatography(HPLC).
- Conditions
- Chronic Periodontitis
- Being tested
- Simvastatin, EDTA, Occlusive membrane, Modified perforated membrane
- Keywords
- Guided tissue membranes, EDTA, Simvastatin
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Simvastatin is a drug used orally for treatment of hypercholesterolemia. It assists in bone regeneration and has anti-inflammatory effect when applied locally in intrabony defects for periodontal therapy.
EDTAOther
Also called Ethylenediaminetetraacitic acid
EDTA is a demineralizing agent used for root surface conditioning.
Occlusive membraneDevice
Also called Resorb resodont forte
Occlusive membrane is the traditional collagen resorbable membrane used in guided tissue regeneration.
Modified perforated membraneDevice
Also called Resorb resodont forte
Modified perforated membrane is the traditional collagen resorbable membrane but modified to be perforated. It is used in guided tissue regeneration
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin/Occlusive membrane | Experimental | open flap procedure, 1.2%simvastatin gel applied and covering the defect with resorbable collagen occlusive membrane . Receives: Drug: Simvastatin; Device: Occlusive membrane |
| Simvastatin/perforated membrane | Experimental | open flap procedure, 1.2% simvastatin gel and covering the defect with resorbable collagen modified perforated membrane. Receives: Drug: Simvastatin; Device: Modified perforated membrane |
| EDTA/Simvastatin/Occlusive membrane | Experimental | open flap procedure, 24% EDTA root surface etching,1.2% simvastatin gel and then coverage of the defect with occlusive membrane. Receives: Drug: Simvastatin; Other: EDTA; Device: Occlusive membrane |
| EDTA/Simvastatin/perforated membrane | Experimental | open flap procedure, 24% EDTA root surface etching, 1.2% simvastatin gel and then coverage of the defect with modified perforated membrane. Receives: Drug: Simvastatin; Other: EDTA; Device: Modified perforated membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth
Probing pocket depth was measured from the free gingival margin to the base of the pocket from baseline to 6 months and 9 months
Measured: Baseline to 9 months
Clinical attachment level
Clinical attachment level was measured from the cementoenamel junction to the base of the pocket from baseline to 6 months and 9 months
Measured: Baseline to 9 months
Plaque index
Plaque index was measured from baseline to 6 months and 9 months
Measured: Baseline to 9 months
Gingival index
Gingival index was measured from baseline to 6 months and 9 months
Measured: Baseline to 9 months
Linear measurements
Linear measurements were measured using Digora software from baseline to 6 months and 9 months
Measured: Baseline to 9 months
Radiodensitometric measurements
Bone density was measured using Digora software from baseline to 6 months and 9 months
Measured: Baseline to 9 months
Secondary outcomes (1)
Simvastatin gingival crevicular fluid levels
Simvastatin gingival crevicular fluid levels availability in cases with and without EDTA root surface etching using HPLC at day 1, 7, 14, 21,and 30
Measured: Day 1, 7, 14, 21 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study startJan 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Rasheed Issa, Ain Shams University
- Investigators
- Ahmed Y Gamal, Professor, Study director, Faculty of dentistry- Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419429
- Sponsor's protocol ID
- FDASU-RECD 12165332
- Status last verified
- Feb 2018
- First submitted
- 17 Jan 2018
- Last updated
- 6 Feb 2018
- 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 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Simvastatin Gel With Perforated Resorbable Membranes in the Treatment of Intrabony Defects in Chronic Periodontitis Patients (Clinical and Biochemical Study)
- ClinicalTrials.gov ID
- NCT03419429
- Acronym / sponsor ID
- FDASU-RECD 12165332
- Conditions
- Chronic Periodontitis
- Keywords
- Guided tissue membranes, EDTA, Simvastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 5 Feb 2018 (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.
Modified perforated membrane (MPM) is considered as a modality that could enable participation of periosteal cells and gingival stem cells which could improve the outcomes of guided tissue regeneration more than the use of the traditional occlusive membrane (OM). Simvastatin (SMV) modulates bone formation by increasing the expression of bone morphogenetic protein 2 and angiogenesis. Ethylenediaminetetraacitic acid (EDTA) found to be effective as low ph etchant for smear layer removal and exposing root surface collagen. The investigators compared the clinical and radiographic outcome of SMV gel combined with MPM to SMV gel combined with OM with and without an associated EDTA gel root surface etching for improving bone regeneration in intrabony defects in chronic periodontitis patients. Moreover, evaluation of SMV gingival crevicular fluid (GCF) levels availability for 30 days in cases with and without EDTA root surface etching was performed.
Detailed description
Forty patients with 40 intrabony defects having chronic periodontitis were randomly assigned into four equal groups to receive open flap procedure, 1.2% SMV gel and covering the defect with OM (Group I), open flap procedure, 1.2% SMV gel and covering the defect with MPM (Group II), open flap procedure, 24% EDTA root surface etching,1.2% SMV gel and then coverage of the defect by OM (Goup III), or open flap procedure, 24% EDTA root surface etching, 1.2% SMV gel and then coverage of the defect by MPM (Group IV). Plaque index, gingival index,probing pocket depth, clinical attachment level, defect base level, crestal bone level, and radiodensitometric measurements were measured at baseline and reassessed at 6 and 9 months after therapy. Additionally, GCF was collected from group I, II, III and IV at 1,7,14, 21, and 30 days in order to evaluate SMV availability and the effect of EDTA root surface etching on its availability using High-performance liquid chromatography(HPLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Simvastatin/Occlusive membrane | Experimental | Drug: Simvastatin, Device: Occlusive membraneopen flap procedure, 1.2%simvastatin gel applied and covering the defect with resorbable collagen occlusive membrane . |
| Simvastatin/perforated membrane | Experimental | Drug: Simvastatin, Device: Modified perforated membraneopen flap procedure, 1.2% simvastatin gel and covering the defect with resorbable collagen modified perforated membrane. |
| EDTA/Simvastatin/Occlusive membrane | Experimental | Drug: Simvastatin, Other: EDTA, Device: Occlusive membraneopen flap procedure, 24% EDTA root surface etching,1.2% simvastatin gel and then coverage of the defect with occlusive membrane. |
| EDTA/Simvastatin/perforated membrane | Experimental | Drug: Simvastatin, Other: EDTA, Device: Modified perforated membraneopen flap procedure, 24% EDTA root surface etching, 1.2% simvastatin gel and then coverage of the defect with modified perforated membrane. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients were all healthy and free from any systemic disease.
- No history of antibiotic therapy or periodontal treatment for at least six months preceding the study.
- Patients were willing and able to return for multiple follow up visits.
- Periodontal defects with
- Good level of oral hygiene (plaque and gingival indices score after initial phase therapy should be less than one).
Key exclusion criteria (4 listed)
- Pregnancy, lactation for female patients.
- Smokers, alcoholics and those receiving any medication that could affect healing of soft tissue and bone as steroids and cyclosporines.
- History of allergic reaction to the medications used.
- Vulnerable groups and handicapped.
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 |
|---|---|---|
| SimvastatinSimvastatin is a drug used orally for treatment of hypercholesterolemia. It assists in bone regeneration and has anti-inflammatory effect when applied locally in intrabony defects for periodontal therapy. | Drug | EDTA/Simvastatin/Occlusive membrane, EDTA/Simvastatin/perforated membrane, Simvastatin/Occlusive membrane, Simvastatin/perforated membrane |
| EDTAAlso: Ethylenediaminetetraacitic acidEDTA is a demineralizing agent used for root surface conditioning. | Other | EDTA/Simvastatin/Occlusive membrane, EDTA/Simvastatin/perforated membrane |
| Occlusive membraneAlso: Resorb resodont forteOcclusive membrane is the traditional collagen resorbable membrane used in guided tissue regeneration. | Device | EDTA/Simvastatin/Occlusive membrane, Simvastatin/Occlusive membrane |
| Modified perforated membraneAlso: Resorb resodont forteModified perforated membrane is the traditional collagen resorbable membrane but modified to be perforated. It is used in guided tissue regeneration | Device | EDTA/Simvastatin/perforated membrane, Simvastatin/perforated membrane |
Primary outcome
Probing pocket depth
Time frame: Baseline to 9 months
Probing pocket depth was measured from the free gingival margin to the base of the pocket from baseline to 6 months and 9 months
Clinical attachment level
Time frame: Baseline to 9 months
Clinical attachment level was measured from the cementoenamel junction to the base of the pocket from baseline to 6 months and 9 months
Plaque index
Time frame: Baseline to 9 months
Plaque index was measured from baseline to 6 months and 9 months
Gingival index
Time frame: Baseline to 9 months
Gingival index was measured from baseline to 6 months and 9 months
Linear measurements
Time frame: Baseline to 9 months
Linear measurements were measured using Digora software from baseline to 6 months and 9 months
Radiodensitometric measurements
Time frame: Baseline to 9 months
Bone density was measured using Digora software from baseline to 6 months and 9 months
1 secondary outcome
Simvastatin gingival crevicular fluid levels
Time frame: Day 1, 7, 14, 21 and 30
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 6 Feb 2018.
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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.
Ahmed Y Gamal, Professor study director
Faculty of dentistry- Ain Shams University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin, EDTA and Occlusive membrane in people with Chronic Periodontitis, run by Ain Shams University.
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 8 inclusion and 4 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 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Probing pocket depth (time frame: Baseline to 9 months). The study lists 6 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 6 Feb 2018.