| CTRI Number |
CTRI/2025/11/097274 [Registered on: 12/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of effect of gum surgery procedure along with connection of posterior teeth with each other on activity of muscle mastication and also improvement in quality of life in individuals having pyorrhoea. |
|
Scientific Title of Study
|
Effect of periodontal therapy with splinting of posterior teeth on masticatory muscles activity and quality of life in stage II, III periodontitis - a prospective randomised control trial. |
| 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 Manish A Ashtankar |
| Designation |
Reader |
| Affiliation |
VYWS Dental College & Hospital Amravati |
| Address |
Room No 16
First Floor
epartment of Periodontology
Room No 16
First Floor
epartment of Periodontology
Amravati
MAHARASHTRA
444602
India |
| Phone |
9284203288 |
| Fax |
|
| Email |
manishashtankar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangesh Phadnaik |
| Designation |
Professor & HOD |
| Affiliation |
Government dental college and Hospital Nagpur |
| Address |
Government Dental College and Hospital, Hanuman Nagar, Medical Chawk, Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9422203650 |
| Fax |
|
| Email |
drmbphadnaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Manish A Ashtankar |
| Designation |
Reader |
| Affiliation |
VYWS Dental College & Hospital Amravati |
| Address |
Room No 16
First Floor
epartment of Periodontology
Room No 16
First Floor
epartment of Periodontology
Amravati
MAHARASHTRA
444602
India |
| Phone |
9284203288 |
| Fax |
|
| Email |
manishashtankar@gmail.com |
|
|
Source of Monetary or Material Support
|
| V.Y.W.S. DENTAL COLLEGE & HOSPITAL AMRAVATI, Tapovan-Wadali Road, Camp Rd, SRPF Colony, Amravati, Maharashtra 444602 |
|
|
Primary Sponsor
|
| Name |
Dr Manish A Ashtankar |
| Address |
DEPARTMENT OF PERIODONTOLOGY
FIRST FLOOR
Room No 16
Pin code 444602 |
| Type of Sponsor |
Other [Self funded by researcher] |
|
|
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 Manish A Ashtankar |
VYWS Dental College & Hospital, Amravati |
Room no 16 First floor Department of Periodontology
Tapovan-Wadali Road, Camp Rd, SRPF Colony, Amravati, Maharashtra 444602
Amravati
MAHARASHTRA |
9284203288
manishashtankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECVYWSDCHA |
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 |
No splinting |
No splinting will be done in control group after flap surgery.
Duration 6 month |
| Intervention |
sEMG recording after splinting of posterior teeth. |
sEMG testing of masticatory muscles will be done in experimental group after splinting of posterior teeth.
At baseline, 6 month after flap surgery and immediately after splinting (6 month after flap surgery) |
| Comparator Agent |
sEMG without splinting |
sEMG testing of masticatory muscles will be done in the control group without splinting of posterior teeth.
Frequency -At baseline and 6 month after flap surgery |
| Intervention |
Splinting |
Splinting of premolars and molars by 22 gauge SS wire and composite in all quadrants.
Frequency only once 6 month after flap surgery
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with Generalised Stage II, III Periodontitis with the following criteria will be selected for the study and control group.
i)Age 30 to 60 years.
ii)Individuals with more than 20 vital teeth with the presence of upper and lower premolars and first, and second molars.
iii)None of the molars & premolars will have a crown, FPD, or endodontic lesion.
iv)With probing pocket depth (PPD) > 4mm and Clinical attachment loss (CAL) > 3mm i.e. Stage II, III Periodontitis. |
|
| ExclusionCriteria |
| Details |
i)Systemic conditions that affect the periodontium and muscles of mastication.
ii)Patients with Temporomandibular joint disorders and Myofunctional Pain Dysfunction Syndrome, Bruxism.
iii)Pregnancy and lactation.
iv)Central nervous system disorders.
v)Individuals with dental implants.
v)History of periodontal or orthodontic treatment in the last 6 months.
Individuals taking antihistamines, sedatives, Homoeopathic medical medicines, or central nervous system depressants, which may interfere with muscular activity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in masticatory muscle activity in individuals with Generalised stage II, III Periodontitis after periodontal therapy along with splinting of Premolars & Molars. |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| An improvement in Quality of individual’s life with Generalised stage II, III Periodontitis after periodontal therapy along with splinting of Premolars & Molars. |
3 years |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
30/11/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - 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 - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - through publication
- For how long will this data be available start date provided 21-08-2023 and end date provided 31-08-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a prospective randomized controlled trial with the primary aim to compare the changes in masticatory muscle activity and Quality of life in individuals with Generalised stage II, and III Periodontitis before and after periodontal therapy along with splinting of Premolars and Molars. the hypothesis behind the study there is a difference in masticatory muscle activity in individuals with Generalised stage II, and III Periodontitis after periodontal therapy and splinting of Premolars and Molars. The primary outcome will be the changes in masticatory muscle activity and an improvement in the Quality of an individual’s life with Generalised stage II, and III Periodontitis after periodontal therapy along with splinting of Premolars and Molars. the secondary outcome will be the advantage of splinting of molars and premolars on masticatory muscles activity because of the summation of PDL mechanoreceptors. |