| CTRI Number |
CTRI/2025/09/095282 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of change in blood glucose levels by dental scaling treatment with or without using laser in Goan patients having diabetes mellitus and gum disease |
|
Scientific Title of Study
|
Assessment of long-term effects of non-surgical periodontal therapy with and without adjunctive laser treatment on periodontal status, glycemic control and systemic inflammation in patients with type 2 diabetes mellitus and chronic periodontitis: a randomized controlled clinical trial in a Goan population |
| 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 SANDEEP ANANT LAWANDE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Goa Dental College and Hospital |
| Address |
Goa Dental College and Hospital, Room No.2, Department of Periodontics, Bambolim,Goa
North Goa
GOA
403202
India |
| Phone |
9890223731 |
| Fax |
|
| Email |
drsanlaw20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SANDEEP ANANT LAWANDE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Goa Dental College and Hospital |
| Address |
Goa Dental College and Hospital, Room No. 2, Department of Periodontics, Bambolim,Goa
North Goa
GOA
403202
India |
| Phone |
9890223731 |
| Fax |
|
| Email |
drsanlaw20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SANDEEP ANANT LAWANDE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Goa Dental College and Hospital |
| Address |
Goa Dental College and Hospital, Room no.2, Department of Periodontics, Bambolim,Goa
North Goa
GOA
403202
India |
| Phone |
9890223731 |
| Fax |
|
| Email |
drsanlaw20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goa Dental College and Hospital, Bambolim, Goa |
|
|
Primary Sponsor
|
| Name |
Dr Sandeep Anant Lawande |
| Address |
Department of Periodontics
Goa Dental College and Hospital
Bambolim Goa 403202 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Goa State Research Foundation |
Porvorim
Goa |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Anant Lawande |
Goa Dental College and Hospital |
Room No.2, Department of Periodontics, Bambolim
North Goa
GOA |
9890223731
drsanlaw20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Dental College and Hospital 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 |
| Comparator Agent |
Control Group (Group I)
|
10 ml of venous blood will be collected from all the subjects at baseline to evaluate serum interleukin-1 level. Serum interleukin-1 level will be determined by ELISA technique using Human Interleukin-1 Elisa kit.
Method: Venous blood samples will be obtained from all subjects at baseline by venepuncture in the antecubital fossa without excessive venous stasis. Blood samples thus obtained will be subjected to centrifugation at 3000 revolutions per minute (rpm) for 10 min at 18oC, and the serum will be frozen at -20oC. Levels of interleukin-1 will be determined by ELISA technique using Human Interleukin-1 Elisa Kit. In addition to this, glycated hemoglobin level (HbA1C) will be assessed for each subject. Clinical periodontal parameters such as bleeding on probing (BOP), Plaque index (Silness and Loe, 1964), Gingival index (Loe and Silness, 1963), Pocket probing depth (PPD), will be recorded for each subject at baseline. In this group, no intervention will be carried out, only oral hygiene instructions will be provided.
|
| Intervention |
Test Group (Group II)
|
10 ml of venous blood will be collected from all the subjects at baseline, 6 months and 12 months after scaling and root planing (SRP), to evaluate serum interleukin-1 level. Serum interleukin-1 level will be determined by ELISA technique using Human Interleukin-1 Elisa kit.
Method: Venous blood samples will be obtained from all subjects at baseline by venepuncture in the antecubital fossa without excessive venous stasis. Blood samples thus obtained will be subjected to centrifugation at 3000 revolutions per minute (rpm) for 10 min at 18oC, and the serum will be frozen at -20oC. Levels of interleukin-1 will be determined by ELISA technique using Human Interleukin-1 Elisa Kit. This will be done at baseline, 6 months and 12 months after SRP. In addition to this, glycated hemoglobin level (HbA1C) will be assessed for each subject at baseline, 6 months and 12 months after SRP. Clinical periodontal parameters such as bleeding on probing (BOP), Plaque index (Silness and Loe, 1964), Gingival index (Loe and Silness, 1963), Pocket probing depth (PPD), will be recorded for each subject at baseline, 6 months and 12 months after SRP. Change in the glycated hemoglobin level and serum interleukin-1 level will be evaluated at baseline and 6 months and 12 months after scaling and root planing (SRP) to determine if any change in the glycated hemoglobin level and serum interleukin-1 level is observed after SRP in subjects with chronic periodontitis with type II diabetes mellitus.
|
| Intervention |
Test Group (Group III)
|
10 ml of venous blood will be collected from all the subjects at baseline, 6 months and 12 months after scaling and root planing (SRP) with laser application, to evaluate serum interleukin-1 level. Serum interleukin-1 level will be determined by ELISA technique using Human Interleukin-1 Elisa kit.
Method: Venous blood samples will be obtained from all subjects at baseline by venepuncture in the antecubital fossa without excessive venous stasis. Blood samples thus obtained will be subjected to centrifugation at 3000 revolutions per minute (rpm) for 10 min at 18oC, and the serum will be frozen at -20oC. Levels of interleukin-1 will be determined by ELISA technique using Human Interleukin-1 Elisa Kit. This will be done at baseline, 6 months and 12 months after SRP with laser application. In addition to this, glycated hemoglobin level (HbA1C) will be assessed for each subject at baseline, 6 months and 12 months after SRP and laser application. Clinical periodontal parameters such as bleeding on probing (BOP), Plaque index (Silness and Loe, 1964), Gingival index (Loe and Silness, 1963), Pocket probing depth (PPD), will be recorded for each subject at baseline, 6 months and 12 months after SRP with laser application. Change in the glycated hemoglobin level and serum interleukin-1 level will be evaluated at baseline and 6 months and 12 months after scaling and root planing (SRP) with laser application to determine if any change in the glycated hemoglobin level and serum interleukin-1 level is observed after SRP and laser application in subjects with chronic periodontitis with type II diabetes mellitus.
|
| Intervention |
Test Group (Group IV)
|
10 ml of venous blood will be collected from all the subjects at baseline, 6 months and 12 months after scaling and root planing (SRP) with antimicrobial photodynamic therapy, to evaluate serum interleukin-1 level. Serum interleukin-1 level will be determined by ELISA technique using Human Interleukin-1 Elisa kit.
Method: Venous blood samples will be obtained from all subjects at baseline by venepuncture in the antecubital fossa without excessive venous stasis. Blood samples thus obtained will be subjected to centrifugation at 3000 revolutions per minute (rpm) for 10 min at 18oC, and the serum will be frozen at -20oC. Levels of interleukin-1 will be determined by ELISA technique using Human Interleukin-1 Elisa Kit. This will be done at baseline, 6 months and 12 months after SRP with antimicrobial photodynamic therapy. In addition to this, glycated hemoglobin level (HbA1C) will be assessed for each subject at baseline, 6 months and 12 months after SRP with antimicrobial photodynamic therapy. Clinical periodontal parameters such as bleeding on probing (BOP), Plaque index (Silness and Loe, 1964), Gingival index (Loe and Silness, 1963), Pocket probing depth (PPD), will be recorded for each subject at baseline, 6 months and 12 months after SRP with antimicrobial photodynamic therapy. Change in the glycated hemoglobin level and serum interleukin-1 level will be evaluated at baseline and 6 months and 12 months after scaling and root planing (SRP) with antimicrobial photodynamic therapy to determine if any change in the glycated hemoglobin level and serum interleukin-1 level is observed after SRP with antimicrobial photodynamic therapy in subjects with chronic periodontitis with type II diabetes mellitus.
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 35 and 70 years of age with confirmed diagnosis of type II diabetes mellitus and generalized chronic periodontitis with 20 or more teeth remaining.
Periodontal pocket depth of 5 mm or more with each quadrant having atleast 3 teeth. |
|
| ExclusionCriteria |
| Details |
Pregnant/lactating women.
Patients who were on antibiotic therapy in the previous six months.
Patients who had undertaken any periodontal therapy in past 6 months.
Patients with any autoimmune disorders
Alcoholics
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in clinical periodontal parameters
Reduction in glycated hemoglobin level
Reduction in serum interleukin-1 level
|
Baseline, 6 months, 12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/10/2025 |
| 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="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
|
Study aims to assess the effects of scaling and root planing (SRP) with and without adjunctive use of laser application on periodontal status, glycemic status and systemic inflammation in patients with chronic periodontitis and type II diabetes mellitus.
OBJECTIVES: 1. To investigate the effect of periodontal therapy on glycemic control in patients with chronic periodontitis with type II diabetes mellitus. 2. To determine the effect of periodontal therapy on systemic inflammation in patients with chronic periodontitis with type II diabetes mellitus. 3. To assess and compare the glycemic control and systemic inflammation with and without periodontal therapy in patients with chronic periodontitis and type II diabetes mellitus. 4. To determine whether adjunctive use of diode laser application with or without antimicrobial photodynamic therapy improves periodontal parameters, glycemic control and systemic inflammation in patients with chronic periodontitis and type II diabetes mellitus. 5. To compare the effects of periodontal therapy with scaling and root planing (SRP) alone with that of combination of SRP and diode laser application or antimicrobial photodynamic therapy on periodontal parameters, glycemic status and systemic inflammation in patients with chronic periodontitis and type II diabetes mellitus.
Patients will be divided into four groups: Group I: No intervention (control group) (n=20) Group II: Scaling and root planing (SRP) (n= 20) Group III: Scaling and root planing (SRP) + diode laser application (n=20) Group IV: Scaling and root planing (SRP) + antimicrobial photodynamic therapy (n= 20)
Periodontal parameters such as bleeding on probing, gingival index, plaque index, pocket probing depth will be recorded for each patient at baseline (for Group I) and at baseline and at the end of 6 months and 12 months (for groups II, III, IV).
Glycated hemoglobin level will be determined and serum interleukin-! level will be evaluated by ELISA technique using Human Interleukin-1 Elisa kit at baseline and after 6 months and 12 months of treatment. |