| CTRI Number |
CTRI/2019/11/022074 [Registered on: 20/11/2019] Trial Registered Prospectively |
| Last Modified On: |
19/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to know the efficiency of muscles used for chewing in patients with gum disease before and after gum surgery. |
|
Scientific Title of Study
|
“Clinical and Electromyographic evaluation of masseter and temporalis muscle activity in periodontitis patients before and after 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 |
E Santosh Vamsi |
| Designation |
Post graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Periodontics and Implantology
block 2
room no 7
Vishnu dental college Vishnupur
Bhimavaram
West Godavari
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8522004877 |
| Fax |
|
| Email |
santoshvamsi09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh KSV |
| Designation |
Associate professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Periodontics and Implantology
block 2
room no 7
Vishnu dental college Vishnupur
Bhimavaram
West Godavari
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8886157669 |
| Fax |
|
| Email |
ksv006@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramesh KSV |
| Designation |
Associate professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Periodontics and Implantology
block 2
room no 7
Vishnu dental college Vishnupur
Bhimavaram
West Godavari
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8886157669 |
| Fax |
|
| Email |
ksv006@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics and Implantology
block 2
room no 7
Vishnu dental college Vishnupur
Bhimavaram
West Godavari |
|
|
Primary Sponsor
|
| Name |
vishnu dental college |
| Address |
Department of Periodontics and Implantology
block 2
room no 7
Vishnu dental college Vishnupur
Bhimavaram
West Godavari |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| E Santosh Vamsi |
Vishnu Dental College |
Department of Periodontics,block 2, room 7
West Godavari
ANDHRA PRADESH |
8522004877
santoshvamsi09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vishnu Ethical Institutional 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 |
Electromyography Analysis |
This is used to compare the masticatory efficiency of temporalis and masseter muscles before and after surgical periodontal therapy. |
| Intervention |
surgical periodontal therapy |
surgical periodontal therapy will be done. |
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group: 23 to 60 years.
2. Controlled Diabetic and hypertensive
patients.
3. More than or equal to 20 teeth and more than or equal to 4 mastication units. (0ne pair of molars in occlusion was considered two units and one pair of premolars in occlusion was considered one unit.)
4. Moderate to severe periodontitis patients with inflammation & periodontal pockets in more than or equal to 4 sites (must include molars) and a depth of more than or equal to 4mm and CAL.
5. Grade I &II mobile teeth.
6. Single crown restorations.
|
|
| ExclusionCriteria |
| Details |
1. Patients who had underwent any periodontal therapy in the past 6 months and those who are on antibiotics.
2. Grade III mobile teeth.
3. Teeth indicated for extraction.
4. Patients with TMJ disorder with clicking sounds/deviation.
5. Patients with implants.
6. Patients using orthodontic appliances.
7. Removable partial dentures.
8. Patients with parafunctional habits
9. Pregnant women
10. Smokers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. muscle activity of masseter and temporalis in periodontitis patients through electromyography.
2. subjective perception of the patient before and after periodontal surgery through OIDP questionnaire |
baseline, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Probing pocket depth
Clinical attachment level
|
baseline, 3 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 2 |
|
Date of First Enrollment (India)
|
28/11/2019 |
| 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="6"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a clinical and electromyographic trial evaluating the masseter and temporalis muscle activity in periodontitis patients before and after surgical periodontal therapy. Primary outcomes are the effect of surgical periodontal therapy on the muscle activity of masseter and temporalis in periodontitis patients through electromyography and the subjective perception of the patient before and after periodontal surgery through OIDP questionnaire which will be assessed at the baseline and 3 months. |