| CTRI Number |
CTRI/2024/11/077408 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Locally delivered agents in chronic periodontitis |
|
Scientific Title of Study
|
Comparative evaluation of locally delivered probiotics Saccharomyces boulardii-prebiotics Fructooligosaccharide mixture and tetracycline fibers as an adjunct to scaling and root planning in the management of patients with chronic periodontitis: A Randomised Clinical Trial |
| 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 Chandrima Biswas |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
| Address |
Department of
Periodontics, Room no.
12, Sri Rajiv Gandhi
College of Dental
Sciences and Hospital, Cholanagar, R. T.
Nagar Post, Bengaluru
Bangalore
KARNATAKA
560032
India |
| Phone |
8240883516 |
| Fax |
|
| Email |
chandrimafeb23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Yadalam |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
| Address |
Department of
Periodontics, Room no.
12, Sri Rajiv Gandhi
College of Dental
Sciences and Hospital, Cholanagar, R. T.
Nagar Post, Bengaluru
Bangalore
KARNATAKA
560032
India |
| Phone |
9844269511 |
| Fax |
|
| Email |
umeshyadalam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandrima Biswas |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
| Address |
Department of
Periodontics, Room no.
12, Sri Rajiv Gandhi
College of Dental
Sciences and Hospital, Cholanagar, R. T.
Nagar Post, Bengaluru
Bangalore
KARNATAKA
560032
India |
| Phone |
8240883516 |
| Fax |
|
| Email |
chandrimafeb23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Rajiv Gandhi College of Dental Sciences and Hospital,
Cholanagar, R.T. Nagar Post, Bengaluru, Karnataka, India PIN- 560032 |
|
|
Primary Sponsor
|
| Name |
Dr Chandrima Biswas |
| Address |
Sri Rajiv Gandhi College of Dental Sciences and Hospital,
Cholanagar, R.T. Nagar Post, Bengaluru, Karnataka, India PIN - 560032 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Chandrima Biswas |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
Department of Periodontics, Room no. 12, Sri Rajiv Gandhi College of Dental Sciences and Hospital, Cholanagar, R.T. Nagar Post, Bengaluru
Bangalore
KARNATAKA |
08240883516
chandrimafeb23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethical Commmittee, Sri Rajiv Gandhi College of Dental Sciences and Hospital |
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 |
| Comparator Agent |
1. Prebiotic-probiotic mixture (probiotic Saccharomyeces
boulardii and prebiotic fructooligosaccharide )
2. Tetracycline fibers(Periodontal plus AB) |
1. Prebiotic-probiotic mixture:
Dose- Following SRP, on one site small increments of the preparation will be taken and
mixed with distilled water until a paste-like consistency was achieved. Sequential
increments of the mixture will be placed until the pocket was entirely filled to the gingival margin and the defect opening will be sealed using periodontal dressing
(Coe-Pac, USA)
Frequency and duration- treatment done at baseline only
Route of administration- Locally delivered to periodontal pockets
2. Tetracycline fibers:
Dose- After SRP, on the other site Saline soaked tetracycline impregnated collagen fibers (Periodontal plus AB) will be gently placed until it fills the pocket and the defect opening will be sealed using periodontal dressing
Frequency and duration- treatment done at baseline only
Route of administration- Locally delivered to periodontal pockets |
| Intervention |
Scaling and root planing |
Scaling and Root planing is done at baseline on all sites |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy males and females participants of 25-55 years having 20 teeth or more except third molars having Chronic Periodontitis patient with at least two periodontal pockets ≥ 5 mm with at least one pocket in each quadrant and clinical attachment level ≥1 mm |
|
| ExclusionCriteria |
| Details |
Patients with any systemic diseases or under antibiotics or anti-inflammatory drugs in the past 6 months or who have history of allergic reactions to tetracycline or Saccahromyces or
Fructooligosaccharide or who have undergone periodontal therapy in the past 6 months or pregnant and Lactating women or Smokers and Tobacco users |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Probing pocket depth, Clinical attachment level and colony forming units of Porphyromonas gingivalis |
baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival index score (Loe and Silness) and Plaque index score (Silness and Loe) |
baseline, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
06/12/2024 |
| 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="1"
Months="0"
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
|
Chronic periodontitis is characterized by inflammation and destruction of the supporting tissues of the teeth, including the gums and bone, primarily caused by bacterial infections. It is of multifactorial etiology mainly the presence of pathogenic bacteria, the absence of “beneficial bacteria†and the susceptibility of the host. Initial therapy focuses on the reduction of periodontopathogens by scaling and root planing (SRP) and oral hygiene instructions. Although initially the number of pathogens can be greatly reduced by Scaling and root planing, periodontal pathogens quickly re-colonize the treated niches in the oral cavity. Thus adjuvant therapies—antibiotic therapy, antimicrobial photodynamic therapy, and probiotic therapy have been used recently. Probiotics have gained attention in the field of periodontal health as a potential adjunctive therapy for chronic periodontitis as it reduce inflammation, improve gum health, and inhibit the growth of periodontal pathogens. The rationale behind using probiotics in chronic periodontitis is conversion of the dysbiotic microbiome to a beneficial symbiotic microbiome thus they are able to promote a healthier balance of oral microbiota by introducing beneficial bacteria, which may help counteract the harmful effects of pathogenic bacteria associated with periodontal disease. Studies have demonstrated that probiotics can reduce periodontopathogens, improve periodontal clinical parameters, decrease the levels of proinflammatory cytokines, and potentiate the effects of SRP. However, the effectiveness of probiotics can vary depending on factors such as the strain, dosage, and formulation used, as well as individual patient characteristics. Saccharomyces boulardii is a non-pathogenic yeast used as a preventive and therapeutic agent for the treatment of a variety of gastrointestinal diseases as a live non-pathogenic microbial food or food supplement that beneficially affects the host by improving its intestinal microbial system. The probiotics use the prebiotics as a food source, which enables them to survive for a longer period of time inside the human body than would otherwise be possible. Local delivery of antimicrobial agents includes oral rinses, subgingival irrigation and controlled release delivery system. They have been evaluated in several forms such as gels, strips, fibers, chips, ointments and using different antimicrobial agents such as tetracycline, doxycycline, metronidazole, minocycline and chlorhexidine. Goodson introduced the use of tetracycline as a local drug delivery agent for the treatment of periodontal diseases. One such local drug delivery system is available in the form of resorbable tetracycline fibers (Periodontal Plus AB®). The tetracycline groups of drug are among the most widely used agents to treat periodontal disease both systemically and also as local drug delivery agent which have the advantage of avoiding the deleterious effect of systemic administration including the development of resistance, suppression of normal flora and poor patient compliance. Tetracycline is a promising drug for controlling progression of periodontal diseases by their ability to reduce microbial burden, to block collagenase activity, and to potentially inhibit bone loss. Meta-analysis published in 2003 reported a significant mean reduction in probing depth (PD) in favor of local tetracycline therapy and suggested more advantage with fibers compared to other devices. Another Meta-analysis published in 2016 showed significant improvement in periodontal parameters such as clinical attachment level (CAL), PD, and sulcular bleeding index in favor of tetracycline as local drug delivery compared to placebo. Saccharomyces is the best studied eukaryote and a valuable tool for most aspects of basic research on eukaryotic organisms due to its unicellular nature and easy amenablity to genetic manipulation. Multiple animal studies have been conducted which have proved that Saccharomyces when used as a local probiotic does not result in any adverse effects on periodontal tissues and when used as single drug or as an adjuvant, the probiotic was effective at controlling periodontitis. However there is very limited knowledge to evaluate its efficacy as a probiotic in humans and its effects on Keystone periodontal pathogen, Porphyromonas gingivalis. So this study is being conducted to evaluate and compare the effect of locally delivered probiotic-prebiotic mixture comprising Saccharomyces boulardi and Fructooligosaccharide with tetracycline fibers as an adjunct to SRP in treating Chronic Periodontitis. |