| CTRI Number |
CTRI/2025/03/082127 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to understand the benefit of two products that is multi-berry gel and tetracycline fibers in the treatment of pyorrhoea patients as a site specific delivery in the gums. |
|
Scientific Title of Study
|
Evaluating the effectiveness of local drug delivery of Multi-berry gel and Tetracycline fibers for the management of periodontitis patients: A randomized control study
|
| 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 Sakshi Romil Shah |
| Designation |
JR 1st year MDS PG |
| Affiliation |
KM Shah Dental College and Hospital |
| Address |
Room no - 7, Department of Periodontology, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth, at and post piperia, taluk waghodia, vadodara, gujarat-391760
Vadodara
GUJARAT
391760
India |
| Phone |
7522971682 |
| Fax |
|
| Email |
sakshiromilshah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasuma Rai |
| Designation |
Professor |
| Affiliation |
KM Shah Dental College and Hospital |
| Address |
Room no - 7, Department of Periodontology, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth, at and post piperia, taluk waghodia, vadodara, gujarat-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9974005760 |
| Fax |
|
| Email |
drjasumaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasuma Rai |
| Designation |
Professor |
| Affiliation |
KM Shah Dental College and Hospital |
| Address |
Room no - 7, Department of Periodontology, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth, at and post piperia, taluk waghodia, vadodara, gujarat-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9974005760 |
| Fax |
|
| Email |
drjasumaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 7, Department of Periodontology, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth, At and Post Piparia, Taluk Waghodia, Vadodara, Gujarat-391760 |
|
|
Primary Sponsor
|
| Name |
Dr Sakshi Romil Shah |
| Address |
Room no - 7, Department of Periodontology, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth, at and post piperia, taluk waghodia, vadodara, gujarat-391760 |
| 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 Jasuma Rai |
KM Shah Dental College and Hospital |
Room number 7, Department of Periodontology, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth, At and Post Piparia, Taluk Waghodia.
Vadodara
GUJARAT |
9974005760
drjasumaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
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 |
Multi-berry gel ( Cranberry and Garcinia Cambogia ) |
Cranberry is a superfruit in many countries including India. The development of two bacterial species, Porphyromonas gingivalis and Fusobacterium nucleatum, linked to pyorrhoea is suppressed by cranberry extract, this berry possess anti-bacterial, anti-oxidant and anti-inflammatory properties. Garcinia cambogia shows strong antioxidant and anti-inflammatory effects. The total duration of the study is 18 months. The follow up of the study will be done at 0,1,3 months. |
| Comparator Agent |
Tetracycline fibers |
Tetracyclines are generally considered to be more effective against Gram-positive bacteria than Gram-negative bacteria and display good activity against most spirochetes as well as many anaerobic and facultative bacteria which is present in pyorrhoea. The other properties of tetracyclines are inhibition of bone resorption, anti-inflammatory actions, and to promote the attachment of fibroblasts and connective tissue to root surfaces and hence it is used in periodontal therapy. The total duration of the study is 18 months. The follow up of the study will be done at 0,1,3 months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy patients of both sexes between 30 and 65 years.
2. Having at minimum two teeth with one proximal site with (clinical attachment level [CAL] of 3-4mm, and (probing pocket depth [PPD] of 5-7mm) - stage II/III. |
|
| ExclusionCriteria |
| Details |
1.Previous use of systemic or local antibiotic, anti-inflammatory drugs or periodontal therapy in the previous 6 months.
2.Allergic to tetracycline, cranberry and garcinia cambogia
3.Smokers
4.Pregnant/lactating woman .
5.Patients on any medication for systemic diseases like diabetes and hypertension etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pocket probing depth, Clinical Attachment Level |
Baseline, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sulcus Bleeding Index and Quigley and Hein’s plaque index as modified by Turesky et al. |
Baseline, 1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="1"
Months="6"
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
|
Pyorrhoea is an infection that leads to the degradation of the areas around the tooth. Cleaning of the teeth by itself does not eliminate infection, since pyorrhoea reside deeper in the tissue, making them unreachable by instruments, hence different treatments like multi-berry and antibiotics are administered. Systemic antibiotics can cause several side effects like toxicity, development of bacterial resistance, and interactions with other drugs. To address this, a local drug delivery method is employed in gums. Cranberry is a superfruit in many countries including India. The development of two bacterial species, Porphyromonas Gingivalis and Fusobacterium Nucleatum linked to pyorrhoea is suppressed by cranberry extract. This berry also possess anti-bacterial, anti-oxidant and anti-inflammatory properties. Garcinia Cambogia shows strong anti-oxidant and anti-inflammatory effects.Tetracyclines are generally considered to be more effective against Gram-positive bacteria than Gram-negative bacteria and display good activity against most spirochetes as well as many anaerobic and facultative bacteria which is present in pyorrhoea. The other properties of tetracyclines are inhibition of bone resorption, anti-inflammatory actions, and to promote the attachment of fibroblasts and connective tissue to root surfaces and hence it is used in periodontal therapy. Thus, the current research investigates the efficacy of clinical parameters involving multi-berry gel or tetracycline fibers as a local drug delivery for management of periodontitis patients. |