| CTRI Number |
CTRI/2024/11/076542 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of periodontal parameters and blood sugar levels before and after teeth scaling with and without daily use of mouthwash for six months in Diabetics and Non - Diabetic patients. |
|
Scientific Title of Study
|
Comparison of effects of non-surgical periodontal therapy with and without chemical plaque biofilm control on status of periodontitis and glycemic control in type 2 diabetic and non-diabetic patients – a randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1315-4315 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivam Agarwal |
| Designation |
PG Student, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Room No 5, Department of Periodontology and Oral Implantology, Uttaranchal Dental And Medical Research Institute Majri Grant Dehradun Uttarakhand
Dehradun
UTTARANCHAL
248140
India |
| Phone |
7017848451 |
| Fax |
|
| Email |
shivam.aggarwal31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aaron F Gomes |
| Designation |
PG Guide, Professor and Head, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Department of Periodontology & Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9860597402 |
| Fax |
|
| Email |
aarongomes@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivam Agarwal |
| Designation |
PG Student, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Room No 5, Department of Periodontology & Oral Implantology, Uttaranchal Dental and Medical Research Institute, Mazri Grant, near Doiwala, Haridwar Highway, Dehradun, Uttarakhand, India. 248140
Dehradun
UTTARANCHAL
248140
India |
| Phone |
7017848451 |
| Fax |
|
| Email |
shivam.aggarwal31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology and Oral Implantology, Uttaranchal Dental And Medical Research Institute Majri Grant Dehradun Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Dr Shivam Agarwal |
| Address |
Room No 5, Department of Periodontology and Oral Implantology, Uttaranchal Dental And Medical Research Institute Majri Grant Dehradun Uttarakhand. India. 248140 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shivam Agarwal |
Uttaranchal Dental And Medical Research Institute Dehradun Uttarakhand |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivam Agarwal |
Uttaranchal Dental And Medical Research Institute |
Room No 5, Department of Periodontology and Oral Implantology, Uttaranchal Dental And Medical Research Institute, Majri Grant, Dehradun, Uttarakhand
Dehradun
UTTARANCHAL |
7017848451
shivam.aggarwal31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC UDMRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Scaling polishing and root planing with chlorhexidine Mouthwash in Diabetic patients |
Scaling, polishing and root planing will be performed once as part of non surgical periodontal therapy. Particpant will perform chemical plaque biofilm control with Chlorhexidine mouthwash as an adjunct to standard tooth brushing for 6 months. This group will include patients diagnosed with periodontal disease and those who are diagnosed as Diabetic |
| Comparator Agent |
Scaling polishing and root planing with chlorhexidine mouthwash in Non - Diabetic patients |
Scaling, polishing and root planing will be performed once as part of non surgical periodontal therapy. Particpant will perform chemical plaque biofilm control with Chlorhexidine mouthwash as an adjunct to standard tooth brushing for 6 months. This group will include patients diagnosed with periodontal disease and those who are Non - Diabetic |
| Intervention |
Scaling polishing and root planing without chlorhexidine mouthwash in Diabetic patients |
Scaling, polishing and root planing will be performed once as part of non surgical periodontal therapy. Particpant will perform standard mechanical plaque biofilm control without use of any chemical plaque biofilm control like Chlorhexidine mouthwash for 6 months. This group will include patients diagnosed with periodontal disease and those who were diagnosed as Diabetic |
| Comparator Agent |
Scaling polishing and root planing without chlorhexidine mouthwash in Non - Diabetic patients |
Scaling, polishing and root planing will be performed once as part of non surgical periodontal therapy. Particpant will perform standard mechanical plaque biofilm control without use of any chemical plaque biofilm control like Chlorhexidine mouthwash for 6 months. This group will include patients diagnosed with periodontal disease and those who are Non - Diabetic |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Indian patient other than presence of dysglycaemia (if any).
Presence of stage I or stage II severity of Periodontitis (case definition of
Periodontitis is given below-with).
Ready to come for 6-month recall.
|
|
| ExclusionCriteria |
| Details |
Lack of motivation and/or compliance.
Moderate/heavy smoking.
Bruxism.
More than 2 missing teeth other than third molars in any one quadrant.
Any medical condition that contraindicates periodontal therapy.
Undergoing orthodontic treatment.
Pregnancy, or under treatment with estrogen/progesterone substitutes or taking oral
contraceptives.
Periodontal surgery in the last six months.
Taken antibiotics course or steroid course in last 2 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HbA1c (Glycosylated haemoglobin) levels |
t0 - basleine; before scaling and polishing
t6 - 6 months after scaling and polishing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque Index, as described by Silness and Löe (1964) |
t0 - basleine; before scaling and polishing
t3 - 3 months after scaling and polishing
t6 - 6 months after scaling and polishing |
| Gingival index as described by Löe and Silness (1963) |
t0 - basleine; before scaling and polishing
t3 - 3 months after scaling and polishing
t6 - 6 months after scaling and polishing |
| Periodontal Bleeding on probing as described by Lang et al., (1990) |
t0 - basleine; before scaling and polishing
t3 - 3 months after scaling and polishing
t6 - 6 months after scaling and polishing |
| Periodontal Pocket Probing Depth |
t0 - basleine; before scaling and polishing
t3 - 3 months after scaling and polishing
t6 - 6 months after scaling and polishing |
| Periodontal Clinical Attachment Level |
t0 - basleine; before scaling and polishing
t3 - 3 months after scaling and polishing
t6 - 6 months after scaling and polishing |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shivam.aggarwal31@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Background: Despite
several investigations, evidence is still controversial regarding the effect of
non-surgical periodontal treatment on diabetes mellitus (DM) and the changes in
periodontal disease status after such treatment.
Aims: This study will evaluate
and compare the changes in glycosylated haemoglobin (HbA1c) levels and
periodontal scores in a cohort of type2 DM patients with periodontitis after
non-surgical periodontal treatment that will include regular mechanical plaque biofilm control instructions combined
with professionally performed scaling and root planing (SRP) versus scores
in same cohort treated with non-surgical periodontal treatment that will
include SRP along with mechanical and chemical plaque biofilm control; as well
as to evaluate and compare changes in similar levels and scores after the two
non-surgical periodontal treatments are performed in an age and sex matched
cohort of non-diabetic patients with periodontitis; over a follow-up period of
6 months.
Materials and methods:
A cohort of 40 participants who are presenting with type 2 DM and stage I or
stage II periodontitis will be selected from the out-patients visiting the
department and an informed consent will be administered. The participants will
be randomized into two groups, in one group mechanical plaque biofilm control
instructions combined with professionally performed scaling and root planing
(SRP), will be performed and in the other group additionally chemical plaque
biofilm control consisting of daily mouthwash with 0.12% chlorhexidine
gluconate will be prescribed. In an age and sex matched cohort consisting of 40
non-diabetics with stage I or stage II periodontitis, identical procedure will
be performed. Periodontal disease scores of plaque index, gingival index,
bleeding on probing, pocket probing depth and clinical attachment levels will
be measured at baseline, and at 3- and 6-months after treatment. HbA1c levels
will be recorded at baseline and at 6 months after treatment.
Data Analysis. The
changes in HbA1c levels and periodontal scores will be compared in each group
in both cohorts. The data will be analyses statistically with standard analysis
of variance at a level of significance of p≤0.05
|