Trial Outcomes & Findings for The Effect of Palatal Brushing on Denture Stomatitis (NCT NCT01643876)

Last Updated: 2014-01-22

Results Overview

Modified Newton classification 0: Healthy mucosa 1: Type IA, Petechiae in a normal palatal tissue, which are usually found around the orifices of the ducts of the palatal mucous glands 2: Type IB, Localized area of inflammation of the denture-bearing area 3: Type II, Generalised area of inflammation of the denture-bearing area 4: Type III, Hyperplasic palatal surface with inflammation of the denture-bearing area Inflammation area index 0: No inflammation 1. Inflammation of the palate extending up to 25 % of the palatal denture-bearing tissue 2. Inflammation of the palate extending between 25 % and 50 % of the palatal denture-bearing tissue 3. Inflammation covering more than 50 % of the palatal denture-bearing tissue Inflammation severity index 0: Normal tissue 1. Mild inflammation 2. Moderate inflammation 3. Severe inflammation Total score for inflammation = area + intensity (range 0 to 6)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

48 participants

Primary outcome timeframe

3 months

Results posted on

2014-01-22

Participant Flow

Recruitment from the prosthodontic clinics of the Université de Montréal and of Ribeirão Preto Dental School. Recruitment period dates: May 2012-February 2013.

Participant milestones

Participant milestones
Measure	Palatal Brushing Palatal brushing after each meal for 3 months. Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing.
Overall Study STARTED	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Palatal Brushing on Denture Stomatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Palatal Brushing n=48 Participants Palatal brushing after each meal for 3 months. Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Age, Continuous	66.0 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment Canada	22 participants n=5 Participants
Region of Enrollment Brazil	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Palatal Brushing n=48 Participants Palatal brushing after each meal for 3 months. Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing.
Palatal Inflammation Modified Newton classification, pre-intervention	3 units on a scale Interval 0.0 to 4.0
Palatal Inflammation Modified Newton classification, post-intervention	3 units on a scale Interval 0.0 to 4.0
Palatal Inflammation Inflammation area index, pre-intervention	2.5 units on a scale Interval 0.0 to 3.0
Palatal Inflammation Inflammation area index, post-intervention	2 units on a scale Interval 0.0 to 3.0
Palatal Inflammation Inflammation severity index, pre-intervention	2 units on a scale Interval 0.0 to 3.0
Palatal Inflammation Inflammation severity index, post-intervention	1 units on a scale Interval 0.0 to 3.0
Palatal Inflammation Total score for inflammation, pre-intervention	5 units on a scale Interval 0.0 to 6.0
Palatal Inflammation Total score for inflammation, post-intervention	3 units on a scale Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: 3 months

Candida colony forming units (CFU), defined as the number of colonies formed on a 75 mm agar plate inoculated with collected samples obtained from A)plaque formed on denture surface and B)palatal mucosa.

Outcome measures

Outcome measures
Measure	Palatal Brushing n=48 Participants Palatal brushing after each meal for 3 months. Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing.
Candida Species Count Colonies from denture surface, pre-intervention	1110 colony forming units (CFUs) Interval 0.0 to 1400000.0
Candida Species Count Colonies from denture surface, post-intervention	860 colony forming units (CFUs) Interval 0.0 to 380000.0
Candida Species Count Colonies from palatal mucosa, pre-intervention	0 colony forming units (CFUs) Interval 0.0 to 3440.0
Candida Species Count Colonies from palatal mucosa, post-intervention	0 colony forming units (CFUs) Interval 0.0 to 2560.0

Adverse Events

Palatal Brushing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Elham Emami

Université de Montréal

Phone: 5143436111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place