| CTRI Number |
CTRI/2020/10/028215 [Registered on: 05/10/2020] Trial Registered Prospectively |
| Last Modified On: |
30/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Checking of effect of abnormal chewing forces on gum disease patients using T- scan digital machine |
|
Scientific Title of Study
|
“EVALUATION OF THE EFFECT OF OCCLUSAL CALIBRATION IN CHRONIC PERIODONTITIS PATIENTS WITH OCCLUSAL TRAUMA USING T- SCAN.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MANISHA SINHA |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
Raja rajeswari dental college and hospital |
| Address |
POST GRADUATE STUDENT, DEPARTMENT OF PERIODONTOLOGY, RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL,NO 14, RAMOHALLI CROSS, MYSORE ROAD, BANGALORE KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
9986264380 |
| Fax |
|
| Email |
drmani0702@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NALINI MS |
| Designation |
PROFESSOR |
| Affiliation |
Raja rajeswari dental college and hospital |
| Address |
DEPARTMENT OF PERIODONTOLOGY, RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL,NO 14, RAMOHALLI CROSS, MYSORE ROAD, BANGALORE KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
|
| Fax |
|
| Email |
drnalinims79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANISHA SINHA |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
Raja rajeswari dental college and hospital |
| Address |
DEPARTMENT OF PERIODONTOLOGY, RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL,NO 14, RAMOHALLI CROSS, MYSORE ROAD, BANGALORE KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
|
| Fax |
|
| Email |
drmani0702@gmail.com |
|
|
Source of Monetary or Material Support
|
| RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
DR MANISHA SINHA |
| Address |
POSTGRADUATE, DEPARTMENT OF PERIODONTOLOGY, RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL, NO 14 RAMOHALLI CROSS, MYSORE ROAD, BANGALORE |
| 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 MANISHA SINHA |
RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL |
ROOM NO 4, DEPARTMENT OF PERIODONTOLOGY
Bangalore
KARNATAKA |
09986264380
drmani0702@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE OF RAARAJESWARI DENTAL COLLEGE AND HOSPITAL |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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 and occlusal calibration |
All the patients will be subjected to scaling and root planing procedures. Occlusal calibration using T scan analysis system which uses an electric sensor strip to objectively record occlusal force and the overall distribution of occlusal contacts, as well as the time order of the contacts during mandibular movement. |
| Intervention |
scaling and root planing and occlusal calibration and correction |
All the patients will be subjected to scaling and root planing procedures. Occlusal calibration using T scan analysis system which uses an electric sensor strip to objectively record occlusal force and the overall distribution of occlusal contacts, as well as the time order of the contacts during mandibular movement. The software shows the location of occlusal contact and their relative pressure that was marked in different colors then corrected using conventional methods. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects should be systemically healthy.
2. Patients with untreated periodontitis with probing depth ≥ 5 mm, clinical attachment loss ≥ 3 mm and radiographic evidence of alveolar bone loss excluding third molars.
3. Presence of first and second molar in each quadrant and no more than 3 teeth missing in upper or lower arch.
4. No obvious malocclusion e.g. deep overbite or deep overjet.
5. No history of temporomandibular disorders.
6. Subjects who are compliant and are able to attend follow up.
7. All the patients should not have received periodontal treatment for at least
6 months prior to the clinical examination.
|
|
| ExclusionCriteria |
| Details |
1. Smokers.
2. Systemic diseases like diabetes mellitus, heart diseases, rheumatoid arthritis, hepatitis and other systemic diseases that can alter the course of periodontal disease.
3. Subjects on any medication taken within the last 6 months which may alter the periodontal status.
4. Pregnant and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Role of occlusion in progression of periodontal disease
2. role of occlusal calibration in chronic periodontitis patients with occlusal trauma using T- scan.
3. compare bony changes and clinical parameters in chronic periodontitis patients with occlusal trauma with or without calibration.
4. elaborate the relevant clinical implications with occlusal trauma in chronic periodontitis patients. |
PREOPERATIVE, 3 AND 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.MODIFIED PLAQUE INDEX BY MOMBELLI ET AL
2.MODIFIED GINGIVAL INDEX BY MOMBELLI ET AL |
3 AND 6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1 |
|
Date of First Enrollment (India)
|
09/10/2020 |
| 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)
|
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)?
Response - NO
|
|
Brief Summary
|
The present study aims to evaluate the effect of occlusal calibration in chronic periodontitis patients with occlusal trauma using T- Scan. All the patients will be subjected to scaling and root planing procedures. In all 30 patients, pre-treatment periapical radiographs and T-Scan analysis will be done. After this, patients will be categorized in two groups:15 patients with no occlusal calibration and 15 patients with occlusal calibration using T-Scan. Occlusal calibration using T scan analysis system which uses an electric sensor strip to objectively record occlusal force and the overall distribution of occlusal contacts, as well as the time order of the contacts during mandibular movement. The software shows the location of occlusal contact and their relative pressure that was marked in different colors then corrected using conventional methods. Following this, post treatment, clinical parameters, periapical radiographs and T-Scan evaluation will be done in all the 30 patients followed by baseline, 3 months and 6 months intervals. |