| CTRI Number |
CTRI/2018/03/012675 [Registered on: 20/03/2018] Trial Registered Prospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study is to compare the effects of laser light treatment and gum surgery in patients with gum disease. |
|
Scientific Title of Study
|
Comparative Evaluation Of The Effectiveness Of An 810nm Diode Laser On Post-Operative Pain,Tissue Response,Probing Pocket Depth, Clinical Attachment Level After Kirkland Flap Surgery: A Randomized Split- Mouth Clinical Trial’ |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
POOJITHAMC |
| Designation |
I year post graduate |
| Affiliation |
coorg institute of dental sciences and hospital |
| Address |
Coorg Instituite of Dental Sciences,
K.K.Campus, Maggula Village,
Virajpet
Coorg District
Karnataka
Pin: 571218
Kodagu
KARNATAKA
571218
India |
| Phone |
9480411275 |
| Fax |
|
| Email |
drpoojitha5194@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRBSJAGADISH PAI |
| Designation |
H.O.D |
| Affiliation |
coorg institute of dental sciences and hospital |
| Address |
Coorg Instituite of Dental Sciences,
K.K.Campus, Maggula Village,
Virajpet
Coorg District
Karnataka
Pin: 571218
Kodagu
KARNATAKA
571218
India |
| Phone |
9448163710 |
| Fax |
|
| Email |
bsjpai@cids.edu |
|
Details of Contact Person
Public Query
|
| Name |
POOJITHAMC |
| Designation |
I year post graduate |
| Affiliation |
coorg institute of dental sciences and hospital |
| Address |
Coorg Instituite of Dental Sciences,
K.K.Campus, Maggula Village,
Virajpet
Coorg District
Karnataka
Pin: 571218
Kodagu
KARNATAKA
571218
India |
| Phone |
9480411275 |
| Fax |
|
| Email |
drpoojitha5194@gmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg Instituite of Dental Sciences,
K.K.Campus, Maggula Village,
Virajpet
Coorg District
Karnataka
Pin: 571218 |
|
|
Primary Sponsor
|
| Name |
POOJITHAMC |
| Address |
Coorg Institute Of Dental Sciences,KK Campus,Maggula,Virajpet
571218 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| POOJITHAMC |
Roon No. 4 Department Of Periodontics & implantology. |
Coorg Institute Of Dental Sciences.KK Campus ,Maggula , Virajpet
571218
Kodagu
KARNATAKA |
9480411275
drpoojitha5194@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intitutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
chronic generalised periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kirkland flap surgery |
Used for elimination of the periodontal pocket |
| Intervention |
kirkland flap with laser debridement. |
810 nm diode laser.Biostimilation woth diode laser. |
| Comparator Agent |
not applicable |
not applicable
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aged 30-60 yrs.
2. Subjects with a minimum complement of 20 teeth.
3. Subjects with 2 contra lateral quadrants with at least 2 teeth with a probing depth≥5mm; CAL≥5mm and gingival index≥1.
4. Subjects who will be indicated for flap surgery.
|
|
| ExclusionCriteria |
| Details |
Subjects with any systemic disease.
Subjects who have undergone any periodontal treatment in the last 6 months.
Subjects who have received antibiotics/anti-inflammatory drugs/steroids in the past 3 months.
Pregnant or lactating women.
Subjects who are tobacco or alcohol users.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Elimination of periodontal pocket |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| For achieving good oral health |
2 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/03/2018 |
| Date of Study Completion (India) |
08/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
08/10/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study protocol will be explained to each
of the selected patient and his/her written consent will be obtained prior to
the commencement of the study. Demographic data of the patients, clinical
parameters will be recorded initially. All patients will be receiving a
treatment phase consisting of oral hygiene instructions, Scaling & root planing
[SRP] ≥ 2 weeks before surgical treatment. After re-evaluation, randomization
of the contra lateral surgical sites will be randomly assigned to control or
test by coin flip. The subjects will be followed up after one week for post-operative
pain and tissue response. The patients will be called for post-surgical follow
up (1 month later) after flap surgery, probing pocket depth and clinical
attachment level will be recorded.
|