PeriodontitisPhase 4NCT04044417
Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis
A Phase 4 study testing currettage, curcumin simvastatin paste and EDTA root conditioning in people with Periodontitis, run by Ain Shams University.
Trial summary
Among the root conditioning materials is the Ethylenediaminetetraacetic acid (EDTA). EDTA exposes the collagen fibers on dentin surfaces and also enhances early cell colonization. Statins have an anti-inflammatory effect, inhibit the bone resorption and stimulate the bone formation. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- currettage, curcumin simvastatin paste and EDTA root conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2016to 3 Oct 2018
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient suffering at least a single posterior 2-3 wall periodontal Pocket of depth ≥ 5 mm, attachment loss ≥3 mm, intrabony component ≥3 mm, plaque index ≤1 (Sillness and Loe, 1964) and sulcus bleeding index ≤1 (Mühlemann \& Son, 1971). All these criteria were determined after phase I conventional periodontal therapy.
- Systemically healthy as evidenced by burket's oral medicine health history question questionnaire (Glick et al., 2008).
- Patients available during follow-up periods
Who cannot join
- Smoking
- Patient unwilling to comply with periodontal hygienic instructions
- Patients under any long-term chronic medication
- Vulnerable individuals
About this study
Official title: Curcumin-Simvastatin Release Profile in the Gingival Crevicular Fluid Following EDTA Root Surface Etching in the Surgical Treatment of Intrabony Periodontal Defects - A Biochemical and Clinical Study
Among the root conditioning materials is the Ethylenediaminetetraacetic acid (EDTA). EDTA exposes the collagen fibers on dentin surfaces and also enhances early cell colonization. Statins have an anti-inflammatory effect, inhibit the bone resorption and stimulate the bone formation. Curcumin is effective in preventing periodontal disease destruction by targeting both bacteria and host inflammatory cells. Curcumin has anti- inflammatory, antioxidant, anticarcinogenic, antiviral, and antimicrobial functions. This study will be carried out to examine the effect of simvastatin-curcumin paste following EDTA root surface etching when used in conjunction with open flap debridement treating deep periodontal pockets (suggesting that it may have positive effect)
Read the detailed description
The present study entailed thirty patients having stage II or stage III, Grade A periodontitis with 30 intrabony defects. Patients were divided into three groups; group I was subjected to open flap debridement only. Group II was subjected to open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin). Group III was subjected to open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).Clinical parameters including plaque index, sulcus bleeding index, probing depth and clinical attachment level were recorded pre-surgical. Moreover, radiographic examination was performed by cone beam computed tomography (CBCT) just before the surgery . Vertical bone defects were exposed by full thickness mucoperiosteal flap following intrasulcular incision and thorough debridement was performed. Group II received local application of curcumin-simvastatin paste .Group III received curcumin-simvastatin paste after debridement and 24 % EDTA. The same initial clinical parameters were recorded three and six months postoperatively. Radiographic measurements were recorded six months post surgically.
- Conditions
- Periodontitis
- Being tested
- currettage, curcumin simvastatin paste, EDTA root conditioning
- Keywords
- periodontitis, curcumin, simvastatin, EDTA
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
currettageProcedure or surgery
Also called surgical treatment of periodontal defects
open flap debridement
curcumin simvastatin pasteDrug
Also called open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin.
EDTA root conditioningDrug
Also called open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
EDTA is an aminopolycarboxylic acid and a colourless, water-soluble solid
| Study group | Role | What they receive |
|---|---|---|
| open flap debridement only | Placebo comparator | surgical treatment of periodontal defects Receives: Procedure: currettage |
| curcumin and simvastatin | Active comparator | open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin). Receives: Procedure: currettage; Drug: curcumin simvastatin paste |
| EDTA, curcumin and simvastatin | Active comparator | open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin). Receives: Procedure: currettage; Drug: curcumin simvastatin paste; Drug: EDTA root conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical score
Probing depth (PD): evaluate the average reduction in probing depth measured in millimeters. Reduction in probing depth indicates that EDTA, simvastatin, and curcumin have positive effects in treatment.
Measured: change from base line to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start25 Aug 2016
- Primary completion5 May 2018
- Study completion3 Oct 2018
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Farouk Mohamed Hussein Elsobky, Ain Shams University
- Investigators
- Ahmed Y Gamal, Professor, Study director, Faculty of dentistry- Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044417
- Sponsor's protocol ID
- FER16 21-M
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curcumin-Simvastatin Release Profile in the Gingival Crevicular Fluid Following EDTA Root Surface Etching in the Surgical Treatment of Intrabony Periodontal Defects - A Biochemical and Clinical Study
- ClinicalTrials.gov ID
- NCT04044417
- Acronym / sponsor ID
- FER16 21-M
- Conditions
- Periodontitis
- Keywords
- periodontitis, curcumin, simvastatin, EDTA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Aug 2016 (actual)
- Primary completion
- 5 May 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 5 Aug 2019 (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.
Among the root conditioning materials is the Ethylenediaminetetraacetic acid (EDTA). EDTA exposes the collagen fibers on dentin surfaces and also enhances early cell colonization. Statins have an anti-inflammatory effect, inhibit the bone resorption and stimulate the bone formation. Curcumin is effective in preventing periodontal disease destruction by targeting both bacteria and host inflammatory cells. Curcumin has anti- inflammatory, antioxidant, anticarcinogenic, antiviral, and antimicrobial functions. This study will be carried out to examine the effect of simvastatin-curcumin paste following EDTA root surface etching when used in conjunction with open flap debridement treating deep periodontal pockets (suggesting that it may have positive effect)
Detailed description
The present study entailed thirty patients having stage II or stage III, Grade A periodontitis with 30 intrabony defects. Patients were divided into three groups; group I was subjected to open flap debridement only. Group II was subjected to open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin). Group III was subjected to open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).Clinical parameters including plaque index, sulcus bleeding index, probing depth and clinical attachment level were recorded pre-surgical. Moreover, radiographic examination was performed by cone beam computed tomography (CBCT) just before the surgery . Vertical bone defects were exposed by full thickness mucoperiosteal flap following intrasulcular incision and thorough debridement was performed. Group II received local application of curcumin-simvastatin paste .Group III received curcumin-simvastatin paste after debridement and 24 % EDTA. The same initial clinical parameters were recorded three and six months postoperatively. Radiographic measurements were recorded six months post surgically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| open flap debridement only | Placebo comparator | Procedure: currettagesurgical treatment of periodontal defects |
| curcumin and simvastatin | Active comparator | Procedure: currettage, Drug: curcumin simvastatin pasteopen flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin). |
| EDTA, curcumin and simvastatin | Active comparator | Procedure: currettage, Drug: curcumin simvastatin paste, Drug: EDTA root conditioningopen flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin). |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient suffering at least a single posterior 2-3 wall periodontal Pocket of depth ≥ 5 mm, attachment loss ≥3 mm, intrabony component ≥3 mm, plaque index ≤1 (Sillness and Loe, 1964) and sulcus bleeding index ≤1 (Mühlemann \& Son, 1971). All these criteria were determined after phase I conventional periodontal therapy.
- Systemically healthy as evidenced by burket's oral medicine health history question questionnaire (Glick et al., 2008).
- Patients available during follow-up periods
Key exclusion criteria (4 listed)
- Smoking
- Patient unwilling to comply with periodontal hygienic instructions
- Patients under any long-term chronic medication
- Vulnerable individuals
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 |
|---|---|---|
| currettageAlso: surgical treatment of periodontal defectsopen flap debridement | Procedure or surgery | EDTA, curcumin and simvastatin, curcumin and simvastatin, open flap debridement only |
| curcumin simvastatin pasteAlso: open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin. | Drug | EDTA, curcumin and simvastatin, curcumin and simvastatin |
| EDTA root conditioningAlso: open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).EDTA is an aminopolycarboxylic acid and a colourless, water-soluble solid | Drug | EDTA, curcumin and simvastatin |
Primary outcome
clinical score
Time frame: change from base line to 6 months
Probing depth (PD): evaluate the average reduction in probing depth measured in millimeters. Reduction in probing depth indicates that EDTA, simvastatin, and curcumin have positive effects in treatment.
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 7 Aug 2019.
- 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.
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 currettage, curcumin simvastatin paste and EDTA root conditioning in people with 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 3 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 7 Aug 2019. 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. Some participants in this study may receive a placebo. 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?
clinical score (time frame: change from base line to 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 7 Aug 2019.