| CTRI Number |
CTRI/2025/03/082135 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Curcumin and Resveratrol combination in addition to teeth cleaning to cure severe gum diseases |
|
Scientific Title of Study
|
Clinical efficacy of combined Curcumin and Resveratrol oral in-situ gels as local
therapeutics in the treatment of stage I and stage II Periodontitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Boyapati Ramanarayana |
| Designation |
Professor, Department of Periodontology |
| Affiliation |
SIBAR INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Periodontology, Second floor, Room number-8, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh,
India, PIN CODE-522509
Department of Periodontology, Second floor, Room number-8, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh,
India, PIN CODE-522509
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9490144365 |
| Fax |
|
| Email |
dr.ramanarayana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Boyapati Ramanarayana |
| Designation |
Professor, Department of Periodontology |
| Affiliation |
SIBAR INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Periodontology, Second floor, Room number-8, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh,
India, PIN CODE-522509
Department of Periodontology, Second floor, Room number-8, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh,
India, PIN CODE-522509
ANDHRA PRADESH
522509
India |
| Phone |
9490144365 |
| Fax |
|
| Email |
dr.ramanarayana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Boyapati Ramanarayana |
| Designation |
Professor, Department of Periodontology |
| Affiliation |
SIBAR INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Periodontology, Second floor, Room number-8, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh,
India, PIN CODE-522509
Department of Periodontology, Second floor, Room number-8, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh,
India, PIN CODE-522509
ANDHRA PRADESH
522509
India |
| Phone |
9490144365 |
| Fax |
|
| Email |
dr.ramanarayana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh, India, PIN
CODE-522509 |
|
|
Primary Sponsor
|
| Name |
Dr Boyapati Ramanarayana |
| Address |
Department of Periodontology, Second floor, Room number-8, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh,India, PIN CODE-522509 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Boyapati Ramanarayana |
Sibar Institute of Dental Sciences |
Department of
Periodontology, Second
floor, Room number-8,
Sibar Institute of Dental
Sciences,
Takkellapadu, Guntur,
Andhra Pradesh, India,
PIN CODE-522509
Guntur
ANDHRA PRADESH |
9490144365
dr.ramanarayana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sibar Institute of Dental Sciences, Guntur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chlorhexidine |
Chlorhexidine gel is given as a local drug delivery agent, which is placed within the gingival sulcus. It is performed in a single application within 24 hours.It has antibacterial activity and it can target to eradicate all the potential periodontal pathogenic bacteria |
| Intervention |
Combination of Curcumin and Resveratrol |
In crude form, both curcumin and trans-resveratrol demonstrate low water solubility, poor bioavailability, rapid metabolism, and clearance.One natural way to improve the pharmacological profile of curcumin and trans-resveratrol is via combinations that encourage synergy. For example, trans-resveratrol and curcumin have been found to have a synergistic effect when combined with each other. |
| Intervention |
Curcumin |
Curcumin longa is a rhizome which has been used since ages due to its anti-inflammatory, antimicrobial, anti-oxidant, antiseptic and anti-mutagenic effect.These properties help in reducing the function of neutrophils during inflammation and inhibit free radical formation. curcumin has been found to inhibit destructive collagenase enzyme MMP-9, reduce alveolar bone loss whilst supporting osteogenesis, decrease pro-inflammatory cytokine production, and resolve red complex bacterial infection and biofilm formation. |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Resveratrol |
Resveratrol have anti inflammatory, anti-microbial and anti- carcinogenic properties. Pro-inflammatory cytokines such as interleukins and tumor necrosis factor will be reduced due to its properties. it was also reported through immunobinding assays, the reduction in destructive proteases such as MMP-9, MMP-2, the decrease in both oxidative and nitrosive stress markers |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Stage I and Stage II Periodontitis.
2. Patients within the age group of 35 to 44 years of age for both genders.
3. Subjects with no history of allergies to the components used in the study
4. Patients with standard oral hygiene practices
5. Apparently healthy individuals |
|
| ExclusionCriteria |
| Details |
1. Patients with habits like any form of tobacco, or alcohol consumption.
2. Systemically compromised patients
3. Pregnant women or lactating mothers
4. Patients who are on medication that influences periodontal health.
5. Patients with impacted teeth, non-functional teeth or prosthetic restorations
6. Patients who will not be able to be attend for follow up visits |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in clinical attachment level
2.Reduction of Periodontal Pocket Probing Depth |
baseline,1 month,3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduced inflammation |
baseline,1 month,3 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periodontal inflammation is initiated by gram-negative tooth-associated microbial flora which elicits a host response, resulting in progressive, irreversible bone and soft tissue destruction. The putative oral pathogens such as Agreegatibacter Actinomycetemcomitans, and Porphyromonas species produce endodontopathogenic materials activating monocytes/macrophages to produce pro-inflammatory vasoactive mediators such as prostaglandins PGE2 and IL-1 which suppress host defense mechanism and destroy periodontal tissues.Research in Phyto sciences, an emerging multidisciplinary science has revealed various medicinal plants holding antimicrobial activity with fewer side effects and decreased toxicity. Extracts of these medicinal plants snatched the eyes of various investigators to evaluate their efficacy.Curcumin has anti-inflammatory, anti microbial, anti-oxidant, antiseptic and anti-mutagenic effects. These properties help in reducing the function of neutrophils during inflammation and inhibit free radical formation.Resveratrol is another herbal medicine with anti inflammatory, anti-microbial and anti- carcinogenic properties. in crude form, both curcumin and trans-resveratrol demonstrate low water solubility, poor bioavailability, rapid metabolism, and clearance.Further to this, trans-resveratrol is also photosensitive and stable within a narrow optimal pH range (pH 6–8), making stability an issue.One natural way to improve the pharmacological profile of curcumin and trans-resveratrol is via combinations that encourage synergy. For example, trans-resveratrol and curcumin have been found to have a synergistic effect when combined with each other.Taking the above facts into account, the present study is planned to compare the clinical efficacy of Curcumin, Resveratrol and Chlorhexidine oral in-situ gels as an adjunct to scaling and root planning in the management of stage-1 and stage-2 periodontitis. |