| CTRI Number |
CTRI/2024/04/066439 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Surgical treatment of Gum diseases with and without LASER |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of diode LASER as an adjunct to open flap debridement for the treatment of chronic periodontitis – a split mouth clinical study |
| 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 Rohith GN |
| Designation |
Resident 2nd year PG Student |
| Affiliation |
Government Dental college and Hospital, Jamnagar |
| Address |
Department of Periodontology and Implantology, Government Dental college & Hospital, Navagam Ghed, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9061314248 |
| Fax |
|
| Email |
drrohithgn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayana Patel |
| Designation |
PG Guide |
| Affiliation |
Government Dental college and Hospital Jamnagar |
| Address |
Govt.Dental college & Hospital,Navagam Ghed,Jamnagar
101 Gulab Avenue Near Park Colony Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9825191911 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohith GN |
| Designation |
Resident 2nd year PG Student, Department of periodontology and implantology |
| Affiliation |
Government Dental college and Hospital Jamnagar |
| Address |
Government Dental college & Hospital,Navagam Ghed,Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
09061314248 |
| Fax |
|
| Email |
drrohithgn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Navagam Ghed, Jamnagar,Gujarat-361008,India |
|
|
Primary Sponsor
|
| Name |
Dr Rohith G N |
| Address |
Govt. Dental College and Hospital Jamnagar,Navagam Ghed,Gujarat-361008 |
| 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 Rohith G N |
Government Dental college and hospital, Jamnagar |
Department of
Periodontology, Room
No. 112, Government Dental college and hospital,
Navagam.
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
9061314248
drrohithgn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MP Shah Medical College and Guru Govind Singh Government Hospital |
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 |
Open flap debridement with LASER as an adjunct |
All Parameters Recorded at baseline
Scaling and root planning will be done for the patients.
After phase 1 the patient will be recalled.
Clinical parameters will be checked.
Patient consent for surgery and LA will be taken.
Local anaesthesia will be injected.
Incision is placed in the area included for surgery.
Flap reflection is done on the buccal and palatal side.
Through debridement is performed.
Inner Surface Of the flap will be lased with a semiconductor laser in contact mode via a 7mm long disposable Fiber optic tip held at an angle of 45 degrees to the inner aspect of the flap from the free gingival margin to the bottom of the apical aspect of the flap for 10 seconds per tooth
Surgical sites will be irrigated with sterile saline
Surgical flaps will be sutured to the presurgical level utilizing sutures
Periodontal Dressing placed
Patient is given post operative instructions
Patient is recalled for follow up after 1 week, 1st, 3rd and 6th month.
|
| Intervention |
Open Flap debridement-Flap surgery |
All Parameters Recorded at baseline
Scaling and root planning will be done for the patients.
After phase 1 the patient will be recalled.
Clinical parameters will be checked.
Patient consent for surgery and LA will be taken.
Local anaesthesia will be injected.
Incision is placed in the area included for surgery.
Flap reflection is done on the buccal and palatal side.
Through debridement is performed.
Surgical sites will be irrigated with sterile saline
Surgical flaps will be sutured to the presurgical level utilizing sutures
Periodontal Dressing placed
Patient is given post operative instructions
Patient is recalled for follow up after 1 week, 1st, 3rd and 6th month.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals aged 25–60 years;
2.Patients requiring flap surgery for at least two sextants in the mouth with a probing pocket depth (PPD) greater than 5 mm;
3.Patients who had given written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients with a history of antibiotic therapy within 6 months;
2.Pregnancy, lactating women and smokers;
3.Patients with systemic diseases such as Bleeding disorders,Immunoinflammatory disorders,Systemic infections, uncontrolled diabetes mellitus,Heart diseses,liver and kidney disorders.
4.Patients who are deemed to be uncooperative; and
5.Patients with poor oral hygiene
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pocket Probing Depth (PPD),
2.Modified sulcular bleeding index (MSBI),
3.Clinical attachment level (CAL)/ relative attachment level (RAL),
4.Wound healing index (WHI),
|
Baseline,1st month,3rd month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| – To compare patients’ response (postoperative pain) following open flap debridement (OFD) with and without adjunctive use of diode laser in patients with periodontitis. |
baseline,1 month,3 month,6 month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/05/2024 |
| Date of Study Completion (India) |
15/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
study will carried out with the aim Compare
and evaluate the adjunctive benefits of a diode laser to conventional surgical
debridement in the treatment of periodontitis, testing the hypothesis that
adjunctive use of diode laser can improve outcomes of surgical periodontal
therapy in patients visiting a Government Dental College and Hospital,
Jamnagar. |