a clinical trial comparing the effectiveness of two mouthrinses to treat gum diseases in patients undergoing fixed orthodontic treament

Not Applicable

Completed

Conditions: Other general symptoms and signs, (2) ICD-10 Condition: R688||Other general symptoms and signs,

Registration Number: CTRI/2018/10/016100

Lead Sponsor: Dr Nikita Patil

Brief Summary: AIM OF STUDY:

To evaluate the Effectiveness of freshly prepared Synbiotic Mouthwash vs freshly prepared Probiotic Mouthwash as an Adjunct to Scaling in Patients with Plaque induced gingivitis along with Fixed Orthodontic Appliances

OBJECTIVES OF THE STUDY:

1. To Compare the efficacy of Chlorhexidine mouthrinse(0.12%) and freshly prepared probiotic mouthrise on plaque induced gingivitis in patient with fixed orthodontic appliances

2. To Compare the efficacy of Chlorhexidine mouthrinse(0.12%) and freshly prepared Synbiotic mouthrise on plaque induced gingivitis in patient with fixed orthodontic appliances patients

3. To Compare the efficacy of freshly prepared synbiotic mouthrinse and freshly prepared probiotic mouthrise on plaque induced gingivitis in patient with fixed orthodontic appliances

4. To Compare the efficacy of warm saline rinse and all of the above on plaque induced gingivitis in patient with fixed orthodontic appliances

STUDY DESIGN

The patients fitting in   the inclusion criteria will be divided into four groups using Computer assisted randomization â€“

Group A, Group B, Group C and Group D

a) Group A: Scaling along with Chlorhexidine mouthrinse(0.12%) (n=20)

b) Group B : Scaling along with freshly prepared Probiotic Mouth rinse (n=20)

c) Group C: Scaling along with freshly prepared Synbiotic mouthrinse (n=20)

d)Group D: Scaling along with warm saline rinse(n=20)

Scaling will be done on all sides using Utrasonic Scaler

Clinical parameters:-

The following clinical parameters were recorded at baseline before ultrasonic scaling in every patient by the examiner:-

1. Gingival index (Loe and Silness-1964)14

2. Papilla bleeding index (Muhlemann-1977)15

3. Bonded bracket plaque index (Kilicoglu et al.) 16

4. Stains- present /absent assessed with the help of magnifying glass

Procedure:

Following initial examination and treatment planning, the subjects will be divided into

Groups A,B,C & D. Those in Group A, B, C and D will be explained to undergo thorough

scaling and root planing (SRP).The patients will be allocated in Groups using computer generated randomization method.

The following instruction will be given to the patient for the use of mouthrinse

1.    The patient will be advised to brush with the toothbrush and toothpaste with modified Bass technique twice daily. Modified Bass technique will be demonstrated to the patients.

2.    The patient will be advised to use 10ml of mouthrinse 30 mins after toothbrushing.

3.    This mouthrinse should be used twice daily for 1 month

4.    Patient will be advised not to eat/drink/rinse/brush 30 mins after the use of mouthrinse.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

1. Minimum of 20 teeth should be present in the dentition .
1. Patients with fixed orthodontic appliances 3) Patients classified as stage II and stage III gingivitis based upon the gingival score given by Loe and Silness 1964.
4)Patient with clinical bleeding on probing present.
1. Patient willing to give the informed consent and willing to comply with the study were selected.

Exclusion Criteria

1)Allergy or hypersensitivity to Chlorhexidine or related compounds.
2)Use of antibiotics within last 3 months.
3)Periodontal pockets >4mm.
4)systemic diseases.
5)Pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3. To Compare the efficacy of freshly prepared synbiotic mouthrinse and freshly prepared probiotic mouthrise on plaque induced gingivitis in patient with fixed orthodontic appliances	baseline, 1month.

Secondary Outcome Measures

Name	Time	Method
1. To Compare the efficacy of Chlorhexidine mouthrinse(0.12%) and freshly prepared probiotic mouthrise on plaque induced gingivitis in patient with fixed orthodontic appliances	2. To Compare the efficacy of Chlorhexidine mouthrinse(0.12%) and freshly prepared Synbiotic mouthrise on plaque induced gingivitis in patient with fixed orthodontic appliances patients
4. To Compare the efficacy of warm saline rinse and all of the above on plaque induced gingivitis in patient with fixed orthodontic appliances	baseline, 1month.

Trial Locations

Locations (1): Nair hospital dental college
🇮🇳
(Suburban), MAHARASHTRA, India
Nair hospital dental college
🇮🇳(Suburban), MAHARASHTRA, India
Dr Nikita Patil
Principal investigator
9699696160
patilnikii19@gmail.com