| CTRI Number |
CTRI/2022/11/047613 [Registered on: 24/11/2022] Trial Registered Prospectively |
| Last Modified On: |
28/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the effectiveness of teeth cleaning alone or with laser for treatment of gum disease who have high blood sugar |
|
Scientific Title of Study
|
A comparative evaluation of the effectiveness of scaling and root planing alone or with the adjunct therapy of laser curettage in chronic periodontitis patients diagnosed with type-2 diabetes mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR CHING NUN SIAM |
| Designation |
POST GRADUATE IN PERIODONTOLOGY |
| Affiliation |
INDERPRASTHA DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PERIODONTOLOGY, ROOM NO 2, SECOND FLOOR, INDERPRASTHA DENTAL COLLEGE AND HOSPITAL,46/1, SAHIBABAD INDUSTRIAL AREA, SITE 4, GHAZIABAD, UTTAR PRADESH
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9862260892 |
| Fax |
|
| Email |
drvualnam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANSHU BLAGGANA |
| Designation |
PROFESSOR |
| Affiliation |
INDERPRASTHA DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PERIODONTOLOGY, ROOM NO 2, SECOND FLOOR, INDERPRASTHA DENTAL COLLEGE AND HOSPITAL,46/1, SAHIBABAD INDUSTRIAL AREA, SITE 4, GHAZIABAD, UTTAR PRADESH
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9953110980 |
| Fax |
|
| Email |
dranshublaggana78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VIKRAM BLAGGANA |
| Designation |
HEAD OF DEPARTMENT AND PROFESSOR |
| Affiliation |
INDERPRASTHA DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PERIODONTOLOGY, ROOM NO 2, SECOND FLOOR, INDERPRASTHA DENTAL COLLEGE AND HOSPITAL,46/1, SAHIBABAD INDUSTRIAL AREA, SITE 4, GHAZIABAD, UTTAR PRADESH
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9811773797 |
| Fax |
|
| Email |
drblaggana@gmail.com |
|
|
Source of Monetary or Material Support
|
| INDERPRASTHA DENTAL COLLEGE AND HOSPITAL,46/1, SAHIBABAD INDUSTRIAL AREA, SITE 4, GHAZIABAD, UTTAR PRADESH
Ghaziabad
UTTAR PRADESH
201010
India |
|
|
Primary Sponsor
|
| Name |
DR CHING NUN SIAM |
| Address |
DEPARTMENT OF PERIODONTOLOGY, ROOM NO 2, SECOND FLOOR, INDERPRASTHA DENTAL COLLEGE AND HOSPITAL,46/1, SAHIBABAD INDUSTRIAL AREA, SITE 4, GHAZIABAD, UTTAR PRADESH |
| 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 CHING NUN SIAM |
DEPARTMENT OF PERIODONTOLOGY, INDERPRASTHA DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF PERIODONTOLOGY, ROOM NO 2, SECOND FLOOR, INDERPRASTHA DENTAL COLLEGE AND HOSPITAL,46/1, SAHIBABAD INDUSTRIAL AREA, SITE 4, GHAZIABAD, UTTAR PRADESH
Ghaziabad
UTTAR PRADESH |
09862260892
drvualnam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
SCALING AND ROOT PLANING ALONE |
ULTRASONIC SCALER USED FOR FULL MOUTH SCALING ONLY ONCE |
| Intervention |
SCALING AND ROOT PLANING WITH LASER ASSISTED CURETTAGE |
ULTRASONIC SCALER USED FOR FULL MOUTH SCALING AND ROOT PLANING USING GRACEY CURETTES FOLLOWED BY CURETTAGE USING BIOLASE EPIC X DIODE LASERS WITH 840 NM IN 10 WATTS ONLY ONCE FOR 5-10 SECONDS PER TOOTH |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Medical history of Type 2 Diabetes Mellitus with HbA1c reading of more than 6.5%
Patients with chronic periodontitis with vertical probing depth of ≥4 mm
Patients is self motivated for good oral hygiene.
Patients who have not undergone any surgical periodontal therapy in last 6 months
Patients who are ready to sign informed written consent and will be able to follow recall protocols
|
|
| ExclusionCriteria |
| Details |
Debilitating systemic or infectious diseases (HIV or hepatitis) or any diseases except diabetes mellitus that affect the periodontium.
Patients taking immunosuppressive drugs or corticosteroids which may compromise the treatment outcome.
Pregnant women or lactating mothers.
Failure to complete the informed consent.
Use of tobacco products either in smoking or smokeless tobacco habit
Poor compliance or failure to maintain good oral hygiene.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IMPROVEMENTS IN CLINICAL PARAMETERS VIZ PLAQUE INDEX, GINGIVAL INDEX, PROBING DEPTH AND CLINICAL ATTACHMENT LEVEL |
12 WEEKS OR 3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN HBA1C |
12 WEEKS |
|
|
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)
|
01/12/2022 |
| 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="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periodontitis and diabetes mellitus have complex and unique bidirectional associations. The two-way relationship between the two chronic diseases is an intersection between environmental, microbiologic, genetic, and immunologic factors. Although periodontitis was understood as the sixth complication of diabetes mellitus, currently the two diseases are considered as “comorbid old friends.†in the same light, periodontal treatment reduces serum levels of inflammatory markers. A meta-analysis of clinical trials that investigated the effect of periodontal treatment on HbA1c levels found an HbA1c decrease of 0.29% at 3 months after periodontal treatment (Simpson et al. 2015). In parallel to HbA1c improvements, reductions in local periodontal inflammation, pocket depths, and low-grade systemic inflammation were observed. Non -surgical periodontal treatment resulted in a better glycemic status of type 2 diabetes patients and demonstrated the importance of oral health in their general health. Another meta-analysis indicated a mean treatment effect of -0.36% HbA1c (CI -0.54, -0.19) compared to no treatment after periodontal therapy (p < 0.0001) (Engrebetson, Kocher 2015). Diode Laser therapy benefits the periodontium directly by eliminating
the pathogens and disinfecting the pockets and indirectly by reducing
the hyper inflammatory status and improves the collagen formation and thus, healing will be accelerated of Diabetes Mellitus patients. DL treatment can provide improved
clinical results when it is used as an adjunct to nonsurgical periodontal
treatment in Chronic periodontitis patients with Diabetes Mellitus. |