| CTRI Number |
CTRI/2020/11/028797 [Registered on: 02/11/2020] Trial Registered Prospectively |
| Last Modified On: |
27/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare two treatment methods (LASER and classical) for upper frenectomy |
|
Scientific Title of Study
|
Comparative evaluation of wound healing after Frenectomy by conventional method or by LASER assisted surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Medha Sharma |
| Designation |
Post Graduate |
| Affiliation |
JSS Academy of Higher Education and Research |
| Address |
Room no. 9, Department of Periodontology, JSS Dental College and Hospital, Mysore
Room no 627 D block, JSS ladies hostel, JSS Medical College, bannimantap, Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
07011103703 |
| Fax |
0821-2548394 |
| Email |
medhasha2312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepika PC |
| Designation |
Professor |
| Affiliation |
JSS Academy of Higher Education and Research |
| Address |
Room no. 9, Department of Periodontology, JSS Dental College and Hospital, Mysore
Room no 627 D block, JSS ladies hostel, JSS Medical College, bannimantap, Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
09902066073 |
| Fax |
0821-2548394 |
| Email |
deepikamysore@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Medha Sharma |
| Designation |
Post Graduate |
| Affiliation |
JSS Academy of Higher Education and Research |
| Address |
Room no. 9, Department of Periodontology, JSS Dental College and Hospital, Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
07011103703 |
| Fax |
0821-2548394 |
| Email |
medhasha2312@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, J.S.S Dental College and Hospital, Mysore |
|
|
Primary Sponsor
|
| Name |
JSS Academy of Higher education and reearch |
| Address |
JSS Academy of Higher education and research, s.s nagar, bannimantap, mysore |
| Type of Sponsor |
Research institution |
|
|
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 Medha |
JSS dental college and Hospital |
Department of Periodontology, Room no 9, J.S.S Dental college and hospital, mysore
Mysore
KARNATAKA |
07011103703
08212548394
medhasha2312@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental College Institution Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z764||Other boarder to healthcare facility, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Test group (LASER assisted surgery) compared with control group (conventional method) |
LASER (Test group) :
The area will be anaesthetized with a local infiltration by using 2% lignocaine with 1:80000 adrenaline.The diode LASER at the power setting of 2.5W will be used in a contact mode and moved, in a paint brush stroke, from the base to the apex of the frenum thereby excising it. Any remnant fiber over the periosteum will be removed by gently sweeping the laser tip and the ablated remnant tissue will be cleaned with gauze soaked in saline. Patient will be recalled further for evaluation of clinical parameters.
Conventional (Control group):
The area will be anaesthetized with a local infiltration by using 2% lignocaine with 1:80000 adrenaline.
The frenum will be engaged with a hemostat which will be inserted into the depth of the vestibule and incisions will be placed on the upper and the undersurface of the hemostat until the hemostat is free.
The triangular resected portion of the frenum with the hemostat will be removed.
A blunt dissection will be done on the bone to relieve the fibrous attachment.
The edges of the diamond shaped wound will be sutured by using 4-0 black silk with interrupted sutures. The sutures will be removed 1 week post-operatively.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Subjects within age group of 18 to 26 years.
Good oral hygiene at the time of the surgery.
Only maxillary anterior frena were included in this study.
All subjects were systemically healthy.
|
|
| ExclusionCriteria |
| Details |
Subjects being treated with antiinflammatories, antibiotics and analgesics.
Pregnant or lactating women.
Having any type of suspicious oral lesions
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing Index |
on day of surgery, 7days,14days,1month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS pain score |
on day of surgery, 7days,14days,1month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2020 |
| 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="0"
Months="2"
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)?
|
|
Brief Summary
|
Patients who
fulfilled the inclusion and exclusion criteria will be divided into Group A and
B. In the first visit, Scaling will be performed and oral hygiene instructions
will be given following which Routine blood investigations will be done. In the next visit, frenectomy for patients in Group A will be performed
by the conventional method; whereas frenectomy for patients in group B will be
done by LASER assisted surgery. Patients will be evaluated for the healing index and VAS on the day of
surgery, 7th day , 14th
day and 1 month after the surgery. Patients will be monitored periodically for oral hygiene maintenance and
recalled for further periodontal therapy as needed. |