| CTRI Number |
CTRI/2020/01/022708 [Registered on: 13/01/2020] Trial Registered Prospectively |
| Last Modified On: |
13/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of low level laser therapy in coronally advanced flap with collagen membrane in the treatment of gingival recession. |
|
Scientific Title of Study
|
Comparative evaluation of the efficacy of coronally advanced flap using collagen membrane with or without low level laser therapy in the treatment of Millers class I and class II gingival recession treatment-A Clinical Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maydina Achom |
| Designation |
Postgraduate student |
| Affiliation |
I.T.S CDSR |
| Address |
Moirangkhom, sougaijam leirak nambul mapal Imphal Manipur
I.T.S Centre for Dental Studies and Research,Muradnagar,Ghaziabad 201206.
department of periodontology and oral implantology. Room no: 5
Imphal West
MANIPUR
795001
India |
| Phone |
7005611421 |
| Fax |
|
| Email |
maydinaachom@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikhil sharma |
| Designation |
Professor and Head of Department |
| Affiliation |
I.T.S CDSR |
| Address |
I.T.S Centre for Dental Studies and Research,Muradnagar
I.T.S Centre for Dental Studies and Research,Muradnagar
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9818077799 |
| Fax |
|
| Email |
nikhilsharma@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maydina Achom |
| Designation |
Postgraduate student |
| Affiliation |
I.T.S CDSR |
| Address |
Moirangkhom Sougaijam leirak nambul mapal Imphal Manipur
I.T.S Centre for Dental Studies and Research,Muradnagar,ghaziabad 201206
department of periodontology and oral implantology. Room no: 5
Imphal West
MANIPUR
795001
India |
| Phone |
7005611421 |
| Fax |
|
| Email |
maydinaachom@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrMaydina Achom |
| Address |
I.T.S-CDSR ,muradnagar ghaziabad |
| 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 |
| DrMaydina Achom |
ITS center for dental science and research |
ITS Dental College Muradnagar Ghaziabad. Department of Periodontology and Oral Implantology. Room no:5
Ghaziabad
UTTAR PRADESH |
7005611421
maydinaachom@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Localised periodontitis.Millers class I or Class II gingival recession |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coronally advanced flap with collagen membrane |
Coronally advanced flap with collagen membrane in treatment of miller class I and II gingival recession |
| Intervention |
coronally advanced flap with collagen membrane and Low level laser therapy |
coronally advanced flap with collagen membrane and low level laser therapy in the treatment of miller class I and II gingival recession.
application of laser inside,outside of flap ,root surface of the tooth |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy subjects.
2. Subjects with age between 18-55 years old.
3. Patients having isolated Miller’s class I or class II Gingival recession with adequate width of attached Gingival.
4. Subjects who were willing to comply with all the study related procedure and willing to sign the informed consent form.
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised Patients.
2. Patients with any history of allergy to the material used in this study.
3. Patients who are on antibiotics or antimicrobial therapy, immunosuppressant drug for the last 3 months.
4. Patients on any drug therapy which is known to influence the periodontium.
5. Patients who have undergone any type of periodontal surgical procedure 6 months prior to the initial examination.
6. Patients who are active tobacco users.
7. Patient showing pulpal exposures, non-vital tooth or active caries or restoration on root surface of tooth to be treated.
8. Pregnant and lactating females.
9. Supra-erupted tooth; High frenal attachment.
10. Subject unable to provide informed consent.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival index, Plaque index, Pocket Probing depth,Gingival recession height, Width of keratinised gingiva,Relative clinical attachment level,Wound healing and Pain score |
baseline, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival index, Plaque index, Pocket Probing depth. |
baseline, 1 month and 3 months |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/01/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
comparative evaluationof the efficacy of coronally advanced flap using collagen membrane with or without low level laser therapy in the treatment of millers class I or II gingival recession. Standardised clinical parameters measured are gingival index, plaque index, width of keratinized gingiva, gingival recession height, pocket probing depth,relative clinical attachment level, wound healing and degree of pain level. |