| CTRI Number |
CTRI/2024/12/077532 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate effectiveness of teeth cleaning alone and with adjunctive use of a gel which releases oxygen in patients suffering from gum disease and type-2 diabetes mellitus - A randomized controlled clinical trial |
|
Scientific Title of Study
|
To evaluate effectiveness of oxygen releasing gel as an adjunct to non-surgical periodontal therapy on salivary and serum chemerin and interleukin-6 levels in patients of periodontitis with type 2 diabetes mellitus- 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 Mehak gupta |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Bathinda |
| Address |
OPD Room no. 3025 c-block , Periodontology Division ,Department of Dentistry All India Institute of Medical Sciences Bathinda
Bathinda PUNJAB 151001 India |
| Phone |
7986307414 |
| Fax |
|
| Email |
mehak.gupta111997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Lata Goyal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Bathinda |
| Address |
OPD Room no. 3026 c-block , Periodontology Division ,Department of Dentistry All India Institute of Medical Sciences Bathinda
Bathinda PUNJAB 151001 India |
| Phone |
8475000284 |
| Fax |
|
| Email |
latagoyal83@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mehak gupta |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Bathinda |
| Address |
OPD Room no. 3025 c-block , Periodontology Division ,Department of Dentistry All India Institute of Medical Sciences Bathinda
Bathinda PUNJAB 151001 India |
| Phone |
7986307414 |
| Fax |
|
| Email |
mehak.gupta111997@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Mandi Dabwali Road, Bathinda, Punjab, India 151001 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bathinda |
| Address |
All India Institute of Medical Sciences, Mandi Dabwali Road, Bathinda, Punjab, India 151001 |
| 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 Mehak Gupta |
All India Institute of Medical Sciences Bathinda |
OPD Room no. 3025 c- block Division periodontology Department of Dentistry All India Institute of Medical Sciences Bathinda Bathinda PUNJAB |
7986307414
mehak.gupta111997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Science AIIMS Bathinda Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oxygen releasing gel Blue M gel ( Along with scaling and root planing) |
patients of periodontitis with Type 2 diabetes mellitus who will receive non-surgical periodontal therapy (Scaling and root planing) with application of oxygen releasing gel and patient will be followed up at 1 month and 3 months |
| Comparator Agent |
None (Scaling and root planing alone ) |
Patients of periodontitis with type -2 diabetes mellitus who will receive non-surgical periodontal therapy (Scaling and root planing) alone and patient will be followed up at 1 month and 3 months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Stage 2 or 3 and Grade B or C Periodontitis patients.
2. Patients with type 2 diabetes mellitus diagnosed atleast from 1 year.
3. HbA1c 6.5 % .
4. Patients on oral hypoglycaemic agents.
5. No periodontal treatment received from last 6 months.
6. Pocket depth of 4mm on atleast 2 site.
7. A total of at least 20 teeth should be present in dentition. |
|
| ExclusionCriteria |
| Details |
1.Current or former smoker.
2.Alcoholic patient.
3.Patient with any other systemic disease.
4.Patients with cancer or history of chemotherapy or radiotherapy.
5.Pregnant and lactating females
6.Patients on Antibiotics, anti-inflammatory drugs from last 6 months.
7.Patients on insulin therapy.
|
|
|
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 |
1. Clinical outcome - Clinical attachment level (CAL), Gingival index , Probing Depth (PD), Plaque index.
2. Immunological outcome - Chemerin and interleukin-6 concentration in saliva and serum.
|
baseline, 8 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Biochemical outcome - HbA1c levels in blood. |
baseline, 12 weeks |
|
|
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 4 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
All the patients included in the study will undergo assessment of HbA1c level before starting of any therapy. Clinical attachment level, probing depth, plaque index, gingival index and sampling site will be evaluated by one examiner. Clinical parameters includes 1)Gingival index by Loe H and Silness J (1963) 2) Periodontal pocket Depth by Carranza FA et al. 2013 - The distance from the gingival margin to the bottom of the gingival sulcus. Probing depth will be recorded on 6 sites of each tooth. 3) Clinical attachment level (CAL) by Carranza FA et al. 2013 – It is the distance from stable reference point that is cementoenamel junction (CEJ) to the base of periodontal pocket. 4)Plaque index by Silness J and Loe H 1964 Randomization And Allocation - The patients will be randomized through a computer generated sequence of random numbers and then group allocation concealment will be done by sealed opaque envelope. GROUP 1 – 20 Patients of periodontitis with type -2 diabetes mellitus who will receive non-surgical periodontal therapy (Scaling and root planing) alone. GROUP 2 – 20 patients of periodontitis with Type 2 diabetes mellitus who will receive non-surgical periodontal therapy (Scaling and root planing) with application of oxygen releasing gel. All the procedures will be done by single operator. Random assignment will be used to place patients in one of the therapy groups. Test group - Patients of periodontitis with type -2 diabetes mellitus who will receive non-surgical periodontal therapy (Scaling and root planing) with application of oxygen releasing gel. Control group - Patients of periodontitis with type -2 diabetes mellitus who will receive non-surgical periodontal therapy (Scaling and root planing) alone. At patient’s first visit, saliva and serum will be collected. Unstimulated saliva will be collected and before collection of saliva patient will be instructed to rinse the mouth thoroughly then patient will be guided to sit comfortable and asked to swallow their saliva first and then bend their heads forwardly and allow the saliva to passively drain into a sterile container which will be transferred into eppendrof tube . For serum analysis venous blood will be collected in a sterile vial without anti-coagulant and will be kept for 1 hour at room temperature to allow blood to clot and after 1 hour serum will be separated by centrifuge. Both serum and saliva will be stored at -80℃ until immunological analysis of levels of chemerin and interleukin-6 by Enzyme linked immunosorbent assay will be performed. Clinical parameters will also be recorded at same time for baseline measurements. After baseline measurements all patients will undergo non-surgical periodontal therapy and in patients under test group we will apply oxygen releasing gel at periodontal pocket sites. Saliva and serum will be collected again for analysis of chemerin and interleukin-6 level by Enzyme linked immunosorbent assay at 8 weeks and 12 weeks. Clinical parameters and will also be recorded after 8 weeks and 12 weeks. HbA1c will be analysed again at 12 weeks. |