| CTRI Number |
CTRI/2025/04/085294 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Action of glucosamine sulfate powder on gum health in gum disease patients. |
|
Scientific Title of Study
|
Comparative evaluation of host modulatory effects of ORTHOBOON Glucosamine sulfate plus Collagen plus Vitamin C as an adjunct to Non-Surgical Periodontal Therapy in the management of chronic periodontitis: A randomized controlled 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 Shashank Deshpande |
| Designation |
MDS - Lecturer |
| Affiliation |
Terna Dental College, Navi Mumbai |
| Address |
101, Department Of Periodontology, Terna Dental College and Hospital, Plot no 12 Nerul, Navi Mumbai-400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9987396073 |
| Fax |
|
| Email |
shashankdesh93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amruta Mahajan |
| Designation |
Postgraduate Student |
| Affiliation |
Terna Dental College, Navi Mumbai |
| Address |
101, Department Of Periodontology, Terna Dental College and Hospital, Plot no 12 Nerul, Navi Mumbai-400706
Thane
MAHARASHTRA
400706
India |
| Phone |
7715866553 |
| Fax |
|
| Email |
dramruta1211@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amruta Mahajan |
| Designation |
Postgraduate Student |
| Affiliation |
Terna Dental College, Navi Mumbai |
| Address |
101, Department Of Periodontology, Terna Dental College and Hospital, Plot no 12 Nerul, Navi Mumbai-400706
MAHARASHTRA
400706
India |
| Phone |
7715866553 |
| Fax |
|
| Email |
dramruta1211@gmail.com |
|
|
Source of Monetary or Material Support
|
| 101, Department Of Periodontology, Terna Dental College and Hospital, Plot no 12, Terna Campus Rd., Opp. Nerul Railway station, Sector 20, Nerul, Navi Mumbai-400706 |
|
|
Primary Sponsor
|
| Name |
Terna Dental College |
| Address |
Terna DENTAL COLLEGE, PLOT 12 NERUL, NAVI MUMBAI-400706 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 AMRUTA YADUNATH MAHAJAN |
Terna Dental College, Navi Mumbai |
101, PG clinic, Department Of Periodontology
Thane
MAHARASHTRA |
07715866553
dramruta1211@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TERNA DENTAL COLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
systemically healthy patients undergoing non-surgical periodontal therapy |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Glucosamine sulfate, Collagen and Vitamin C |
subjects will undergo phase I therapy, followed by 500 mg of host modulating agent orally in powder form thrice daily for 30 days. Subjects will be advised to divide 500 mg powder into three parts (1:1:1) and mix each in a cup of water. The clinical parameters will be recorded at baseline and post 30 days, namely, bleeding index (BI), gingival index (GI), probing pocket depth (PPD) and clinical attachment loss (CAL). |
| Comparator Agent |
Scaling And Root Planing |
Subjects in the control group undergo phase-I therapy. The clinical parameters will be recorded at baseline and post 30 days, namely, bleeding index (BI), gingival index (GI), probing pocket depth (PPD) and clinical attachment loss (CAL). |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects between age groups of 20 and 60 years, subjects with stage II grade A periodontitis, systemically healthy subjects and those willing to give informed consent and willing to follow the protocol of the study. |
|
| ExclusionCriteria |
| Details |
1. Subjects receiving diuretics, steroids and oral contraceptives.
2. Subjects with allergies to materials used in the study.
3. Current or former smokers.
4. Pregnant or lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the efficacy of host modulating agent as an adjunt to scaling and root planing in the non-surgical management of patients with chronic periodontitis.
2. To evaluate the efficacy of scaling and root planing in the non-surgical management of patients with chronic periodontitis.
3. To compare the efficacy of host modulating agent as an adjunct to non-surgical therapy in the management of patients with chronic periodontitis. |
Baseline and after 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The clinical parameters evaluated were, namely, bleeding index (BI), gingival index (GI), probing pocket depth (PPD) and clinical attachment loss (CAL). |
Baseline and after 30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
22/04/2025 |
| 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="0"
Months="0"
Days="30" |
|
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
|
AIM: To evaluate
and compare the effect of host modulating agent as an adjunct to
non-surgical periodontal therapy in the management of patients with chronic periodontitis.
OBJECTIVES: 1. To evaluate the efficacy of host modulating agent as an adjunt to scaling and root planing in the non-surgical management of patients with chronic periodontitis. 2. To evaluate the efficacy of scaling and root planing in the non-surgical management of patients with chronic periodontitis. 3. To compare the efficacy of host modulating agent as an adjunct to non-surgical therapy in the management of patients with chronic periodontitis.
The clinical parameters evaluated were bleeding index (BI), gingival index
(GI), probing pocket depth (PPD) and clinical attachment loss (CAL).
These parameters will be evaluated at baseline and after 30 days. Based on the results obtained it will be evaluated whether the use of host modulating agent can provide any additional benefit in improvement in clinical parameters in patients with chronic periodontitis. |