Chronic PeriodontitisPhase 4NCT02442453
Effect of Scaling and Root Planing Along With Topical Application of Commercially Available Curcuma Longa Gel on Superoxide Dismutase and Malondialdehyde Levels in Saliva of Chronic Periodontitis Patients
A Phase 4 study testing Topical application of curenext gel in people with Chronic Periodontitis, run by Tatyasaheb Kore Dental College.
Trial summary
Periodontitis is initiated by microbial biofilm but its progression is mediated by an abnormal host response to biofilm microorganisms. In a myriad of possible mechanisms that cause periodontal tissue destruction reactive oxygen species (ROS) play an important role. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Topical application of curenext gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2014
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients within age group of 30 to 55 years.
- Systemically healthy individuals.
- Patients with chronic generalized periodontitis (based on American Academy of Periodontology classification 1999).
Who cannot join
- Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy, xerostomia).
- Patients on antioxidants, antibiotics and anti-inflammatory drugs.
- Those receiving periodontal treatment in last six months prior to inception of study
- History of smoking, tobacco chewing, alcohol consumption.
- Pregnant and lactating women.
About this study
Periodontitis is initiated by microbial biofilm but its progression is mediated by an abnormal host response to biofilm microorganisms.
In a myriad of possible mechanisms that cause periodontal tissue destruction reactive oxygen species (ROS) play an important role. Imbalance between antioxidant defense system of body and ROS lead to a deleterious situation called oxidative stress.
Read more
Superoxide dismutase (SOD) is the key enzyme of body's antioxidant defense system whereas malondialdehyde (MDA) is product of lipid peroxidation due to ROS. Free radicals and ROS have short half lives in vivo of 10-6 to 10-9 seconds. Hence measurement of ROS is done by measuring the concentration of biomarkers of tissue destruction.
For treating periodontal disease, conventional mechanical therapy comprising of scaling and root planing (SRP) along with timely maintenance has been a gold standard and any other therapy considered for treating periodontitis should always be used as an adjunctive and never in lieu of it.
Curcumin, a hydrophobic polyphenol, is a principal active constituent of turmeric. Mechanism of action of curcumin is twofold-its role as a strong antioxidant and as a strong antibacterial. Its analgesic, anti-inflammatory and antiseptic properties offer additional benefits.Periodontitis is a chronic disease of oral cavity accompanied by increased oxidative stress. Therefore the clinical application of a natural antioxidant in the form of curcuma longa can be beneficial in reducing oxidative stress and as an adjuvant in treatment of chronic periodontitis.
Read the detailed description
Aim was to establish efficacy of curcuma longa gel as a topical antioxidant to alleviate oxidative stress associated with chronic periodontitis.The objectives were-1) To evaluate the presence of oxidative stress by biochemical evaluation of SOD levels and free radical damage in the form of MDA levels in whole saliva of chronic periodontitis patients.
- To show efficacy of curcuma longa gel as topical antioxidant agent on activity of SOD and lipid peroxidation product MDA.
- To compare SOD and MDA levels after SRP and SRP plus topical application of curcuma longa gel.
- To compare the clinical parameters such as Plaque index (PI), Gingival index (GI), Sulcus bleeding index (SBI), Probing depth (PD), Clinical attachment level (CAL) between test group (TG) and control group (CG).
- Conditions
- Chronic Periodontitis
- Being tested
- Topical application of curenext gel, Placebo
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical application of curenext gelDrug
Also called curcuma longa topical gel, curenext gel
Topical application of curcuma longa gel along with scaling and root planing in chronic periodontitis subjects
PlaceboDrug
Topical application of placebo gel along with scaling and root planing in chronic periodontitis subjects
| Study group | Role | What they receive |
|---|---|---|
| curcuma longa | Active comparator | curenext gel containing curcuma longa i.e. turmeric has strong antioxidant and antiinflammatory properties.
Test group:Topical application twice daily for ten minutes after brushing for four weeks. Receives: Drug: Topical application of curenext gel |
| Placebo gel | Placebo comparator | Placebo gel consists of corbopol 934 polymer and triethonalamine. Control group:Topical application twice daily for ten minutes after brushing for four weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superoxide dismutase antioxidant enzyme levels in saliva of chronic periodontitis subjetcs
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startJan 2014
- Primary completionNov 2014
- Study completionDec 2014
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tatyasaheb Kore Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR.DHANASHREE RAVINDRA AGARWAL, Tatyasaheb Kore Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442453
- Sponsor's protocol ID
- DHANASHREE786
- Status last verified
- Apr 2015
- First submitted
- 28 Apr 2015
- Last updated
- 13 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Scaling and Root Planing Along With Topical Application of Commercially Available Curcuma Longa Gel on Superoxide Dismutase and Malondialdehyde Levels in Saliva of Chronic Periodontitis Patients
- ClinicalTrials.gov ID
- NCT02442453
- Acronym / sponsor ID
- DHANASHREE786
- Conditions
- Chronic Periodontitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tatyasaheb Kore Dental CollegeUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 May 2015 (estimated)
- 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.
Periodontitis is initiated by microbial biofilm but its progression is mediated by an abnormal host response to biofilm microorganisms.
In a myriad of possible mechanisms that cause periodontal tissue destruction reactive oxygen species (ROS) play an important role. Imbalance between antioxidant defense system of body and ROS lead to a deleterious situation called oxidative stress.
Superoxide dismutase (SOD) is the key enzyme of body's antioxidant defense system whereas malondialdehyde (MDA) is product of lipid peroxidation due to ROS. Free radicals and ROS have short half lives in vivo of 10-6 to 10-9 seconds. Hence measurement of ROS is done by measuring the concentration of biomarkers of tissue destruction.
For treating periodontal disease, conventional mechanical therapy comprising of scaling and root planing (SRP) along with timely maintenance has been a gold standard and any other therapy considered for treating periodontitis should always be used as an adjunctive and never in lieu of it.
Curcumin, a hydrophobic polyphenol, is a principal active constituent of turmeric. Mechanism of action of curcumin is twofold-its role as a strong antioxidant and as a strong antibacterial. Its analgesic, anti-inflammatory and antiseptic properties offer additional benefits.Periodontitis is a chronic disease of oral cavity accompanied by increased oxidative stress. Therefore the clinical application of a natural antioxidant in the form of curcuma longa can be beneficial in reducing oxidative stress and as an adjuvant in treatment of chronic periodontitis.
Detailed description
Aim was to establish efficacy of curcuma longa gel as a topical antioxidant to alleviate oxidative stress associated with chronic periodontitis.The objectives were-1) To evaluate the presence of oxidative stress by biochemical evaluation of SOD levels and free radical damage in the form of MDA levels in whole saliva of chronic periodontitis patients.
- To show efficacy of curcuma longa gel as topical antioxidant agent on activity of SOD and lipid peroxidation product MDA.
- To compare SOD and MDA levels after SRP and SRP plus topical application of curcuma longa gel.
- To compare the clinical parameters such as Plaque index (PI), Gingival index (GI), Sulcus bleeding index (SBI), Probing depth (PD), Clinical attachment level (CAL) between test group (TG) and control group (CG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| curcuma longa | Active comparator | Drug: Topical application of curenext gelcurenext gel containing curcuma longa i.e. turmeric has strong antioxidant and antiinflammatory properties. Test group:Topical application twice daily for ten minutes after brushing for four weeks. |
| Placebo gel | Placebo comparator | Drug: PlaceboPlacebo gel consists of corbopol 934 polymer and triethonalamine. Control group:Topical application twice daily for ten minutes after brushing for four weeks. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients within age group of 30 to 55 years.
- Systemically healthy individuals.
- Patients with chronic generalized periodontitis (based on American Academy of Periodontology classification 1999).
Key exclusion criteria (5 listed)
- Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy, xerostomia).
- Patients on antioxidants, antibiotics and anti-inflammatory drugs.
- Those receiving periodontal treatment in last six months prior to inception of study
- History of smoking, tobacco chewing, alcohol consumption.
- Pregnant and lactating women.
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 |
|---|---|---|
| Topical application of curenext gelAlso: curcuma longa topical gel, curenext gelTopical application of curcuma longa gel along with scaling and root planing in chronic periodontitis subjects | Drug | curcuma longa |
| PlaceboTopical application of placebo gel along with scaling and root planing in chronic periodontitis subjects | Drug | Placebo gel |
Primary outcome
Superoxide dismutase antioxidant enzyme levels in saliva of chronic periodontitis subjetcs
Time frame: one month
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 13 May 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical application of curenext gel in people with Chronic Periodontitis, run by Tatyasaheb Kore Dental College.
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 5 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 13 May 2015. 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?
Superoxide dismutase antioxidant enzyme levels in saliva of chronic periodontitis subjetcs (time frame: one month). 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 13 May 2015.