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Clinical Trials/CTRI/2018/02/012182
CTRI/2018/02/012182RecruitingNot Applicable

Comparison of effectiveness of Manual and Powered toothbrushes in reduction of plaque and gingivitis-A randomized controlled trial.

Pichika Swathi1 site in 1 country50 target enrollmentStarted: July 12, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
2)Plaque Index (Loe and Sillness), (range:0-3)

Study Overview

Brief Summary

AIM OF THE STUDY:

To assess the effectiveness of manual andpowered toothbrushes in controlling plaque and gingivitis among dental studentsof The Oxford Dental college and Hospital, Bengaluru.

OBJECTIVE OF THESTUDY:

To assess and to compare the effectiveness ofmanual and powered toothbrushes in the reduction of plaque and gingivitis overa period of six months.

SOURCE OF DATA:

First and second year B.D.S students of TheOxford Dental College and Hospital, Bengaluru.

STUDY DESIGN:

The study design will be Single blinded randomizedcontrolled trial (RCT). The sample size consists of 50 dental students (firstand second year B.D.S) of both the genders. The subjects will be randomly divided into two groups  (Group –A and group–B) by a second investigator using a lottery method  and brushingtechnique will be demonstrated and instructed to brush twice a day for 2minutes (once in the morning and once during night before sleeping).  Baseline scores will be recorded and scaling and polishing will be done for allthe subjects. Group –A will be consisting of 25 subjects and will be given manualtoothbrushes [Oral-B Pro Health-soft] and will be instructed to use ModifiedBass method of brushing technique.  Group- B will be consisting of 25 subjects and will be given poweredtoothbrushes [Oral-B Crossaction] and will be instructed to use the brush withthe bristles perpendicular to gingival margin or sulcus.

Subjects will be recalled at 7th, 14th,45thday, 3rd month and 6th month.  The gingival scores will be recorded by a blinded assessor using Loe andSilness (1963) gingival index and the amount of plaque using Loe and Silness plaqueindex (1964) after using a Disclosing agent (two-tone).

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Investigator Blinded

Eligibility Criteria

Ages
19.00 Year(s) to 25.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Good general health.
  • •No history of periodontal therapy during the past 3 months.
  • •Full complement of teeth present, except third molars.

Exclusion Criteria

  • •Use of any antibiotics that could affect the state of the gingival tissues.
  • •Who are undergoing or planning to undergo orthodontic treatment.
  • •Subjects with multiple prosthesis.
  • •Subjects who are already using powered toothbrushes.

Outcomes

Primary Outcomes

2)Plaque Index (Loe and Sillness), (range:0-3)

Time Frame: 7th day, 14th day, 45th day, 3rd month, 6th month

1)Gingival Index(Loe and Sillness),(range:0-3)

Time Frame: 7th day, 14th day, 45th day, 3rd month, 6th month

Secondary Outcomes

  • Reduction in the plaque score.(6 months)

Investigators

Sponsor
Pichika Swathi
Sponsor Class
Other [self]

Study Sites (1)

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