| CTRI Number |
CTRI/2024/09/073289 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Use of Pomegranate fruit Gel in addition to teeth cleaning to cure severe gum diseases |
|
Scientific Title of Study
|
Evaluation of clinical efficacy of Punica granatum epicarp extract, seed and whole fruit juice concentrate loaded thermo-reversible hydrogel as local drug delivery system 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 |
| 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
Guntur
ANDHRA PRADESH
522509
India
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 |
| 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
Guntur
ANDHRA PRADESH
522509
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9490144365 |
| Fax |
|
| Email |
dr.ramanarayana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Boyapati Ramanarayana |
| Designation |
Professor |
| 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
Guntur
ANDHRA PRADESH
522509
India
Guntur
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
Guntur,
ANDHRA PRADESH
522509
India |
| 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 |
Department of Periodontology, 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
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 thermo-reversible hydrogel |
Chlorhexidine thermo-reversible hydrogel 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 |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Punica granatum epicarp extract loaded thermo-reversible hydrogel |
Punica granatum epicarp extract loaded thermo-reversible hydrogel 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 and promotes wound healing
|
| Intervention |
Punica granatum seed loaded thermo-reversible hydrogel |
Punica granatum seed loaded thermo-reversible hydrogel 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 and promotes wound healing |
| Intervention |
Punica granatum whole fruit juice concentrate loaded thermo-reversible hydrogel |
Punica granatum whole fruit juice concentrate loaded thermo-reversible hydrogel 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 and promotes wound healing |
|
|
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.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 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| better wound healing (PISA index) |
baseline,1 month and 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)
|
16/09/2024 |
| 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) |
Not Yet Recruiting |
|
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
|
The primary goal of periodontal therapy is removal of the biofilm deposits and create an environment conducive for the shift of microbiome from pathobionts to symbionts. This is often achieved by the gold standard- scaling and root planning (SRP) procedure, alone or with adjunctive administration of systemic or local antimicrobial agents, and surgical periodontal therapy, if required. However, use of systemic antimicrobials were shown to have adverse effects such as drug toxicity, acquired bacterial resistance, poor patient compliance and unwanted drug interactions. To tackle these limitations, local delivery of antibacterial agents into periodontal pocket is being extensively used. The benefits of using local drug delivery include better patient compliance, enhanced pharmacokinetic response, greater access and ability to position the drug adjacent to the disease and ability to lower total dosage of the drug at a more controlled concentration. Similarly, phytotherapy has long been a source of medicinal products and over the years there have been many attempts to use herbal medicines for the treatment of chronic periodontitis, with the advantage of few side effects and cost-effectiveness.Natural products are the drugs of choice due to novelty in their chemical structure and mechanism of action. Ayurvedic medicine frequently refers to Punica granatum, sometimes known as pomegranate, as "a pharmacy unto itself" because of its prophylactic, anthelmintic, styptic, laxative, diuretic, bactericidal, and antifungal qualities. Peel (the inedible portion) makes up about half of the weight of the fruit; the remaining 50% is made up of seeds (10%), juice (40%) and arils (the edible portion). Bioactive substances include punicalagins, flavones, flavanones, anthocyanins, ascorbic acid, ellagic acid, gallic acid, caffeic acid, catechin, epigallocatechin, quercetin, tannins, and rutin are abundant in the peel and juice. The remarkable antioxidant, anti-inflammatory, anti-atherosclerotic, antihypertensive, anti-mutagenic and wound-healing qualities of P. granatum fruit are attributed to these substances.Due to its unique properties it is used extensively in the treatment of periodontitis.Taking the
above facts into account, the present study is planned prepare
and evaluate the clinical
efficacy of pomegranate
fruit extract loaded thermo-reversible hydrogel as an adjunct to scaling and
root planning in
the management of
Stage I and stage
II Periodontitis. |