| CTRI Number |
CTRI/2024/05/067422 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Statin mixed toothpaste on patients with gum disease |
|
Scientific Title of Study
|
Effect of 2% Atorvastatin medicated dentifrice on patients with chronic periodontitis |
| 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. Pranavi J |
| Designation |
Post graduate |
| Affiliation |
KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES |
| Address |
Room no. 7, Third floor, Department of Periodontology, Karpaga Vinayaga Institute of Dental Sciences, GST road, Chinna kolambakkam, Palayanoor (PO), Chengalpattu (DT),
Madhuranthakam.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9941592993 |
| Fax |
|
| Email |
pranavi@kids.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Lakshmiganthan |
| Designation |
Professor |
| Affiliation |
KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES |
| Address |
Room No.7, Third floor, Department of Periodontology, Karpaga Vinayaga Institute of Dental Sciences, GST road, Chinna kolambakkam, Palayanoor (PO), Chengalpattu (DT), Madhuranthakam
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9940724656 |
| Fax |
|
| Email |
drlakshmiganth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pranavi J |
| Designation |
Post graduate |
| Affiliation |
KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES |
| Address |
Room No.7, Third floor, Department of Periodontology, Karpaga Vinayaga Institute of Dental Sciences, GST road, Chinna kolambakkam, Palayanoor (PO), Chengalpattu (DT), Madhuranthakam
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9941592993 |
| Fax |
|
| Email |
pranavi@kids.edu.in |
|
|
Source of Monetary or Material Support
|
| Room No.7, Third floor, Department of Periodontology, Karpaga Vinayaga Institute of Dental Sciences, GST road, Chinna kolambakkam, Palayanoor (PO), Chengalpattu (DT),
Madhuranthakam, Tamil Nadu- 603308, India. |
|
|
Primary Sponsor
|
| Name |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
GST road, Chinna kolambakkam, Palayanoor (PO), Chengalpattu (DT), Madhuranthakam |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pranavi J |
KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES |
Room no. 7, Third floor,
Department of
Periodontology, GST road, Chinna kolambakkam, Palayanoor (PO), Chengalpattu (DT),
Madhuranthakam, Tamil Nadu-603308.
Kancheepuram
TAMIL NADU |
9941592993
pranavi@kids.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE - KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M272||Inflammatory conditions of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2% Atorvastatin medicated dentifrice |
2% Atorvastatin medicated dentifrice is prescribed to the patients
Dose: 0.5ml of toothpaste
Frequency: Twice daily
Duration: 3 months |
| Comparator Agent |
Conventional dentifrice |
Conventional dentifrice prescribed to the patient.
Dose: 0.5ml of toothpaste
Frequency:Twice daily
Duration: 3 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy individuals
Periodontitis patients with probing pocket depths more than 4 mm
|
|
| ExclusionCriteria |
| Details |
Individuals with any form of systemic illness
Individuals under any systemic medications
Individuals receiving antibiotic therapy or nonsteroidal anti inflammatory drugs during the previous two months
periodontal treatment during the previous 6 months
Use of oral topical agents like mouthwash, gum paints before 3 months and during the study
Smokers
Pregnancy
lactation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To access the efficacy of with 2% Atorvastatin medicated dentifrice on chronic periodontitis.
|
Baseline, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Co-relate the effect of 2% Atorvastatin with clinical parameters:
Bleeding on probing
Probing Depth
Clinical Attachment level
Gingival Index
|
Baseline, 6 months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
03/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
TITLE:
Effect of 2%
Atorvastatin medicated dentifrice on patients with chronic periodontitis
INTRODUCTION:
Periodontitis is an inflammatory disease which is
characterized by a progressive destruction of the supporting tissues of the tooth. Local factors like dental plaque,
calculus and occlusal trauma and various systemic factors cause periodontits.
STATINS [(HMG-CoA) reductase
inhibitors] are potent Anti-hyperlipidemic drugs used as First-line drug in
Coronary Heart Disease. Some pleiotropic effects of statins include Anti-inflammatory, Anti-oxidative, Anti-bacterial, and maintenance of plaque stability .
AIM:
To access the effect of
2% Atorvastatin medicated dentifrice on chronic periodontitis using
clinical parameters such as Bleeding on
probing (BOP), Probing Depth (PD), Clinical Attachment loss (CAL), Gingival
Index (GI).
METHODOLOGY:
36 patients were
randomly selected and divided into Test - 2% Atorvastatin medicated dentifrice group
(18 patients) and control group dentifrice (18 patients).
RESULTS:
Both groups showed
greater reduction in clinical parameters at 3 month follow up. Test group
showed a significant decrease in mean PD, mean CAL, BOP and GI when compared to
control group.
CONCLUSION:
2% Atorvastatin
medicated dentifrice is effective in improving clinical parameters on patients
with chronic periodontitis
|