| CTRI Number |
CTRI/2021/08/035988 [Registered on: 26/08/2021] Trial Registered Prospectively |
| Last Modified On: |
12/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation Of Two Different Maintaenance Protocols In Type-2 Diabetic Patients Undergoing Non- Surgical Periodontal Therapy |
|
Scientific Title of Study
|
Comparative Evaluation Of Two Different Maintaenance Protocols In Type-2 Diabetic Patients Undergoing Non- Surgical Periodontal Therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CV Sruthi Vyaasini |
| Designation |
MDS 2nd Year |
| Affiliation |
J.N.Kapoor DAV (c) Dental college Yamuna Nagar , Haryana |
| Address |
Department Of Periodontology and Oral Implantology, Room No.- 8, J.N.Kapoor DAV (c) Dental college Yamuna Nagar , Haryana
Department Of Periodontology and Oral Implantology, Room No.- 8, J.N.Kapoor DAV (c) Dental college Yamuna Nagar , Haryana
Yamunanagar
HARYANA
132001
India |
| Phone |
09541924677 |
| Fax |
|
| Email |
cvsruthivyaasini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nymphea Pandit |
| Designation |
Professor and HOD |
| Affiliation |
J.N.Kapoor DAV (c) Dental college Yamuna Nagar , Haryana |
| Address |
Department Of Periodontology and Oral Implantology, Room No.- 8, J.N.Kapoor DAV (c) Dental college Yamuna Nagar , Haryana
Department Of Periodontology and Oral Implantology, Room No.- 8, J.N.Kapoor DAV (c) Dental college Yamuna Nagar , Haryana
Yamunanagar
HARYANA
135001
India |
| Phone |
9416493962 |
| Fax |
|
| Email |
drnymphea68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nymphea Pandit |
| Designation |
Professor and HOD |
| Affiliation |
J.N.Kapoor DAV (c) Dental college Yamuna Nagar , Haryana |
| Address |
Department Of Periodontology and Oral Implantology, Room No.- 8, J.N.Kapoor DAV (c) Dental college Yamuna Nagar , Haryana
Department Of Periodontology and Oral Implantology, Room No.- 8, J.N.Kapoor DAV (c) Dental college Yamuna Nagar , Haryana
Yamunanagar
HARYANA
135001
India |
| Phone |
9416493962 |
| Fax |
|
| Email |
drnymphea68@gmail.com |
|
|
Source of Monetary or Material Support
|
| J.N.Kapoor DAV (c) Dental college Yamuna Nagar , Haryana |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 CV Sruthi Vyaasini |
J.N.Kapoor D.A.V (C) Dental College, Yamunanagar 135001 |
Department Of Periodontology and Oral Implantology, Room No.- 8, J.N.Kapoor D.A.V (C) Dental College, Yamunanagar 135001
Yamunanagar
HARYANA |
9541924677
cvsruthivyaasini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Pardeep Kohli,Institutional Ethical Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Brushing twice per day |
brushing twice per day using dentifrice |
| Intervention |
Water irrigation device |
The subjects who fit within the inclusion criteria on careful case examination will be treated with phase I therapy which includes supra gingival scaling and root planing. After 1 week of phase I therapy, the baseline parameters will be recorded. After this, the patients who are randomly allocated to the study group will be instructed to use a powered oral irrigator following brushing twice daily (morning and evening). The patients will be using the irrigator with a sub gingival tip and will be advised to follow the instructions provided with the powered irrigator using a full reservoir of water. They will be given demonstration at the baseline and subjects will be performing a supervised sub gingival irrigation at this visit to ensure proper usage.Regular dentifrice will be used by both the groups during the study. The control group will be told to brush along with the use of commercially available floss during the study period.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:7,20,21
Type 2 diabetic patients (HbA1c < 7%) with generalized chronic periodontitis according to classification by AAP by Armitage.
Subjects who are on oral hypo-glycemic agents or insulin injections and prescribed diet in combination or separately. They should be diabetic for >1 year and on the same type and dose of diabetic medication for past 6 months.
Patients who are in good physical condition and do not have any major illness or serious medical condition or transmissible disease.
Patients willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:7,8,19,22,23
History of systemic antibiotic usage over the past 4 months
Pregnant or lactating women
Non-surgical periodontal treatment within past 6 months
Use of immunosuppressive medications
Subjects with intake of supplemental ascorbic acid
Subjects with history of prolonged drug use that interfere with coagulation system, e.g. Coumarin derivatives
History of severe cardiovascular, hematological, renal, hepatic and immunological disorders
Patients who are smokers and alcoholics
Patient not willing to give informed consent
|
|
|
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 |
Gingival index (GI)
Plaque index (PI)
Oral hygiene index (OHI-S)
Gingival bleeding index (GBI)
Pocket depth(PD)
Clinical attachment loss (CAL)
|
BASELINE
1 MONTH AFTER BASELINE
2 MONTHS AFTER BASELINE
4 MONTHS AFTER BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Inflammatory markers
HbA1c
|
BASELINE
1 MONTH AFTER BASELINE
2 MONTHS AFTER BASELINE
4 MONTHS AFTER BASELINE |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
27/08/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Diabetes mellitus and periodontal diseases are amongst the most prevalent disorders in the human population.For many years, attempts have been made to relate the two disorders.After years of research, it has been established that periodontal disease and diabetes mellitus share a two way relationship. Diabetes mellitus has many complications systemically and one of its complications is periodontitis. Conversely, periodontitis is more than a localized oral infection and may cause changes in the systemic physiology. Type 1 diabetes is presumed to originate from autoimmune process and is controlled by insulin administration only. Also, type 1 diabetes accounts for only 5-10% of all cases of diabetes. Type 1 diabetics, in general are too young to develop moderate or severe forms of periodontitis. Thus, our focus is usually directed towards association of periodontitis with type 2 diabetes. There is evidence to support that controlling periodontal infection plays an important role in the overall management of type 2 diabetics. An effective periodontal treatment within diabetics may inhibit the production of pro inflammatory mediators.Thus, periodontal treatment and follow up might be considered in the treatment plan of diabetic patients especially in poorly controlled glycemic level patients. Although, a major milestone has been reached, we need to have a complete understanding on the management and care of the periodontal disease in diabetic patients.It has also been suggested that use of water irrigation as an adjunctive therapy along with non surgical periodontal treatment may have an adjunctive value in establishing a more healthy periodontal environment. There is paucity of literature related to the use of oral sub gingival home irrigation as an adjunct to non- surgical periodontal therapy in type 2 diabetics.Hence, the purpose of our study is aimed at treating type 2 diabetic patients with generalized chronic periodontitis by non- surgical periodontal therapy along with the adjunctive use of sub gingival water irrigation system as homecare maintenance for a period of 3 months and compare the value of clinical and diabetic parameters in order to evaluate the efficacy of our treatment. |