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CTRI Number  CTRI/2024/04/066034 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 21/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Testing Two Different Treatments for Gum Health in Braces Wearers: Laser Therapy vs. Oxygen Gel 
Scientific Title of Study   Comparison of low level laser therapy and oxygen based oral gel as an adjunct to scaling and root planing on gingival inflammation in orthodontic patients with fixed appliances A split mouth randomized 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 Radhika Hedda 
Designation  Designation Post graduate 
Affiliation  Shri Dharmasthala Manjunatheshwara university 
Address  Shri Dharmasthala Manjunatheshwara College Of Dental Sciences and Hospital, department of periodontics(Room no 7) Sattur Dharwad 580009 Dharwad KARNATAKA 580009 India
sdm dental collage and hospital
Dharwad
KARNATAKA
580001
India 
Phone  8296793392  
Fax    
Email  radhikahedda0@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swati B Setty  
Designation  Professor and Head  
Affiliation  Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital Sattur Dharwad 
Address  Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital, department of periodontics(Room 7) Sattur Dharwad Dharwad KARNATAKA 580009 India
sdm dental collage and hospital
Dharwad
KARNATAKA
580001
India 
Phone  9845680773   
Fax    
Email  drssetty@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swati B Setty  
Designation  Professor and Head 
Affiliation  S.D.M. College of Dental Sciences and Hospital, Dharwad, Karnataka 
Address  Shri Dharmasthala Manjunatheshwara College Of Dental Sciences and Hospital, department of periodontics(Room no 7) Sattur Dharwad 580009 Dharwad KARNATAKA 580009 India
sdm dental collage and hospital
Dharwad
KARNATAKA
580001
India 
Phone  9845680773   
Fax    
Email  drssetty@gmail.com  
 
Source of Monetary or Material Support  
Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital Sattur Dharwad  
 
Primary Sponsor  
Name  radhika hedda  
Address  Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital Sattur Dharwad  
Type of Sponsor  Other [self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Radhika Hedda  SDM college of dental sciences and hospital   Shri Dharmasthala Manjunatheshwara College Of Dental Sciences and Hospital, department of periodontics(Room no 7) Sattur Dharwad 580009 Dharwad KARNATAKA 580009 India
Dharwad
KARNATAKA 		 8296793392

radhikahedda0@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital -IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  gingivitis  
Patients  (1) ICD-10 Condition: K050||Acute gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  To assess the efficacy of – Low level LASER therapy, oxygen based oral gel and scaling and root planing in the treatment of gingival inflammation in patients undergoing fixed   - Full mouth scaling and root planning will be done for all patients - Allocation of groups (split mouth technique) o GROUP A- oxygen based oral gel (blue®m gel) o GROUP B -Low-level LASER therapy,(IndiLaseâ„¢ 660nm wavelength) o GROUP C1-Control (Scaling and root planing) o GROUP C2-Control (Scaling and root paning) - The following clinical parameters will be recorded at baseline, 7th and 14th day – 1. Gingival index [Loe and Silness, 1963] 2. Plaque index [Silness and Loe, 1964] 3. Gingival bleeding index [Ainamo and Bay, 1975] - Patients of all groups will be given uniform oral hygiene instructions. total duration of intervention will be 14 days. 
Comparator Agent  To compare the efficacy of LLLT, oxygen based oral gel and scaling and root planing in the treatment of gingival inflammation in patients undergoing fixed   - Full mouth scaling and root planning will be done for all patients - Allocation of groups (split mouth technique) 1) GROUP A- oxygen based oral gel (blue®m gel) 2) GROUP B -Low-level LASER therapy,(IndiLaseâ„¢ 660nm wavelength) 3) GROUP C1-Control (Scaling and root planing) 4) GROUP C2-Control (Scaling and root paning) -The following clinical parameters will be recorded at baseline, 7th and 14th day 1. Gingival index (GI) [Loe and Silness, 1963] 2. Plaque index (PI) [Silness and Loe, 1964] 3. Gingival bleeding index (GBI) [Ainamo and Bay, 1975] - Patients of all groups will be given uniform oral hygiene instructions. - total duration wil be 14 days  
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA-
1) Aged between 17 and 25 years who received active orthodontic treatment for at least 4 to 6 months.

2) Participants with at least 24 natural teeth (excluding 3rd molars).

3) Participants with gingival index score of more than 1 (Loe and Silness, 1963)
 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA-
1) Medically compromised patients
2) Those requiring special health care needs
3) Patients having a history of antibiotic intake for last 3 months.
4) Patients who had used any type of antibacterial mouthwash 2 weeks before the study  smokers
5) pregnant or lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess the efficacy of –
a) Low level LASER therapy (LLLT) in the treatment of gingival inflammation in patients undergoing fixed orthodontic treatment.
b) Oxygen based oral gel in the treatment of gingival inflammation in patients undergoing fixed orthodontic treatment.
c) Scaling and root planing in the treatment of gingival inflammation in patients undergoing fixed orthodontic treatment.


 		 14 days


 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacy of LLLT, oxygen based oral gel and scaling and root planing in the treatment of gingival inflammation in patients undergoing fixed orthodontic treatment.
 		 14 days  
 
Target Sample Size   Total Sample Size="11"
Sample Size from India="11" 
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)   17/05/2024 
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="3"
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 - NO
Brief Summary  

Research question - What are the comparative effects of low level laser therapy and oxygen based oral gel on reducing gingival inflammation in orthodontic patients with fixed appliances?

-OBJECTIVE OF THE STUDY-

1) To assess the efficacy of –

- Low level LASER therapy (LLLT) in the treatment of gingival inflammation in patients undergoing fixed orthodontic treatment.

- Oxygen based oral gel in the treatment of gingival inflammation in patients undergoing fixed orthodontic treatment.

- Scaling and root planing in the treatment of gingival inflammation in patients undergoing fixed orthodontic treatment.

 

2. To compare the efficacy of above treatment modalities

INCLUSION CRITERIA-

- Aged between 17 and 25 years who received active orthodontic treatment for at least 4 to 6 months.

- Participants with at least 24 natural teeth (excluding 3rd molars).

- Participants with gingival index score of more than 1 (Loe and Silness, 1963)

 

EXCLUSION CRITERIA-

- Medically compromised patients 

- Those requiring special health care needs

- Patients having a history of antibiotic intake for last 3 months. 

- Patients who had used any type of antibacterial mouthwash 2 weeks before the study Ø smokers

- Pregnant or lactating women

 

STUDY PROCEDURE

        - Screening for selection of patients

        - Full mouth scaling and root planning will be done for all patients

        - Allocation of groups (split mouth technique)

 GROUP  A- oxygen based oral gel (blue®m gel) 

 GROUP B -Low-level LASER therapy,(IndiLaseâ„¢ 660nm wavelength)  

 GROUP C1-Control (Scaling and root planing)

 GROUP C2-Control (Scaling and root paning)

       The following clinical parameters will be recorded at baseline,

7th and 14th day – 

1.      Gingival index (GI) [Loe and Silness, 1963]

2.      Plaque index (PI) [Silness and Loe, 1964]

3.      Gingival bleeding index (GBI) [Ainamo and Bay, 1975]

      Patients of all groups will be given uniform oral hygiene instructions.

 

Benefits from study –

Fixed orthodontic appliances make oral hygiene maintenance difficult and may result in gingivitis. Adjunctive oral hygiene procedures such as SRP, application of topical gel or laser irradiation may be beneficial. 

 
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