FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 â€“ 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.

 
Close