Trial Outcomes & Findings for A Clinical Study to Evaluate the Efficacy of a Range of Dental/Denture Products for Improved Oral Health in Partial Denture Wearers (NCT NCT04290624)
NCT ID: NCT04290624
Last Updated: 2023-11-18
Results Overview
The BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. To perform the assessment, a probe was inserted into the gingival crevice to a depth of approximately 1 millimeter \[mm\] and then run around the tooth (at approximately 60 degrees to the long axis of the tooth) gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Three scores were recorded bucally/labially (distal, body, mesial sites) and 3 scores lingually/palatally (distal, body, mesial sites). All scorable teeth in 1 quadrant were probed first (approximately 30 seconds) before recording the number of gingival units which bled. The BI scoring included 3-point scale ranged from 0 to 2, where 0=no bleeding, 1=bleeding within 30 seconds of probing, 2=bleeding immediately on probing. Sites with a score of 1 or 2 were classified as 'bleeding' sites. Higher score indicates worst outcome.
COMPLETED
PHASE4
58 participants
Week 12
2023-11-18
Participant Flow
The study was conducted at a single center in the United Kingdom (UK).
A total of 61 participants were screened for entry into the study, of whom 58 were enrolled and 49 were randomized to a treatment (24 participants in the intervention group and 25 participants in the non-intervention group) and 48 participants completed the study.
Participant milestones
| Measure |
Intervention Group
Participants were instructed to use a dentifrice containing 0.454 percent (%) weight/weight (w/w) stannous fluoride, COREGA denture foaming cleanser and mouth rinse containing 90 parts per million (ppm) sodium fluoride. Participants brushed with a strip of the dentifrice (full brush head) applied to the full length of the toothbrush head for 2 minutes followed by 2 pumps of denture cleanser foam brushed onto removable partial denture (RPD) for 90 seconds and 10 milliliters (ml) of mouth rinse for swished around the mouth for 1 minute. Participants applied all these products topically orally twice daily (morning and evening) for 12 weeks.
|
Non-intervention Group
Participants did not receive any products and continued with their existing dental/denture hygiene practices and were instructed not to make changes to either their established habits or to the products they use following screening.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Intervention Group
Participants were instructed to use a dentifrice containing 0.454 percent (%) weight/weight (w/w) stannous fluoride, COREGA denture foaming cleanser and mouth rinse containing 90 parts per million (ppm) sodium fluoride. Participants brushed with a strip of the dentifrice (full brush head) applied to the full length of the toothbrush head for 2 minutes followed by 2 pumps of denture cleanser foam brushed onto removable partial denture (RPD) for 90 seconds and 10 milliliters (ml) of mouth rinse for swished around the mouth for 1 minute. Participants applied all these products topically orally twice daily (morning and evening) for 12 weeks.
|
Non-intervention Group
Participants did not receive any products and continued with their existing dental/denture hygiene practices and were instructed not to make changes to either their established habits or to the products they use following screening.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Clinical Study to Evaluate the Efficacy of a Range of Dental/Denture Products for Improved Oral Health in Partial Denture Wearers
Baseline characteristics by cohort
| Measure |
Intervention Group
n=23 Participants
Participants were instructed to use a dentifrice containing 0.454% w/w stannous fluoride, COREGA denture foaming cleanser and mouth rinse containing 90 ppm sodium fluoride. Participants brushed with a strip of the dentifrice (full brush head) applied to the full length of the toothbrush head for 2 minutes followed by 2 pumps of denture cleanser foam brushed onto RPD for 90 seconds and 10 ml of mouth rinse for swished around the mouth for 1 minute. Participants applied all these products topically orally twice daily (morning and evening) for 12 weeks.
|
Non-intervention Group
n=25 Participants
Participants did not receive any products and continued with their existing dental/denture hygiene practices and were instructed not to make changes to either their established habits or to the products they use following screening.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.2 Years
STANDARD_DEVIATION 9.68 • n=5 Participants
|
60.5 Years
STANDARD_DEVIATION 10.30 • n=7 Participants
|
60.4 Years
STANDARD_DEVIATION 9.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: mITT Population.
The BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. To perform the assessment, a probe was inserted into the gingival crevice to a depth of approximately 1 millimeter \[mm\] and then run around the tooth (at approximately 60 degrees to the long axis of the tooth) gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Three scores were recorded bucally/labially (distal, body, mesial sites) and 3 scores lingually/palatally (distal, body, mesial sites). All scorable teeth in 1 quadrant were probed first (approximately 30 seconds) before recording the number of gingival units which bled. The BI scoring included 3-point scale ranged from 0 to 2, where 0=no bleeding, 1=bleeding within 30 seconds of probing, 2=bleeding immediately on probing. Sites with a score of 1 or 2 were classified as 'bleeding' sites. Higher score indicates worst outcome.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Participants were instructed to use a dentifrice containing 0.454% w/w stannous fluoride, COREGA denture foaming cleanser and mouth rinse containing 90 ppm sodium fluoride. Participants brushed with a strip of the dentifrice (full brush head) applied to the full length of the toothbrush head for 2 minutes followed by 2 pumps of denture cleanser foam brushed onto RPD for 90 seconds and 10 ml of mouth rinse for swished around the mouth for 1 minute. Participants applied all these products topically orally twice daily (morning and evening) for 12 weeks.
|
Non-intervention Group
n=25 Participants
Participants did not receive any products and continued with their existing dental/denture hygiene practices and were instructed not to make changes to either their established habits or to the products they use following screening.
|
|---|---|---|
|
Mean Bleeding Index (BI) at Week 12
|
0.45 Score on a scale
Standard Error 0.036
|
0.76 Score on a scale
Standard Error 0.034
|
SECONDARY outcome
Timeframe: Week 6 and Week 12Population: mITT Population.
Number of gingival bleeding sites were measured during BI assessment. BI assesses the severity and number of bleeding points elicited on probing as a measure of gingival condition. To perform the assessment, a probe was inserted approximately 1 mm into the gingival sulcus (at approximately 60 degrees) and moved around the tooth, from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. Sites which showed signs of bleeding immediately on probing or within 30 seconds of probing were classified as a bleeding sites.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Participants were instructed to use a dentifrice containing 0.454% w/w stannous fluoride, COREGA denture foaming cleanser and mouth rinse containing 90 ppm sodium fluoride. Participants brushed with a strip of the dentifrice (full brush head) applied to the full length of the toothbrush head for 2 minutes followed by 2 pumps of denture cleanser foam brushed onto RPD for 90 seconds and 10 ml of mouth rinse for swished around the mouth for 1 minute. Participants applied all these products topically orally twice daily (morning and evening) for 12 weeks.
|
Non-intervention Group
n=25 Participants
Participants did not receive any products and continued with their existing dental/denture hygiene practices and were instructed not to make changes to either their established habits or to the products they use following screening.
|
|---|---|---|
|
Mean Number of Bleeding Sites (NBS) at Week 6 and Week 12
Week 6
|
53.1 Number of sites
Standard Error 3.40
|
81.7 Number of sites
Standard Error 3.26
|
|
Mean Number of Bleeding Sites (NBS) at Week 6 and Week 12
Week 12
|
52.9 Number of sites
Standard Error 3.65
|
80.8 Number of sites
Standard Error 3.50
|
SECONDARY outcome
Timeframe: Week 6 and Week 12Population: mITT Population.
The MGI focuses on the visual symptoms of gingivitis (redness, texture, edema). The MGI was assessed for the facial and lingual/palatal gingiva of all evaluable teeth, four sites per tooth (facial surface - papilla and margin; lingual/palatal surface - papilla and margin). The MGI scoring included 5-point scale ranged from 0 to 4, where 0=Absence of inflammation, 1=Mild inflammation: slight change in color, little change in texture of any portion of the marginal or papillary gingival unit, 2=Mild inflammation: criteria as (1) but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit, 4=Severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Higher score indicates worst outcome.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Participants were instructed to use a dentifrice containing 0.454% w/w stannous fluoride, COREGA denture foaming cleanser and mouth rinse containing 90 ppm sodium fluoride. Participants brushed with a strip of the dentifrice (full brush head) applied to the full length of the toothbrush head for 2 minutes followed by 2 pumps of denture cleanser foam brushed onto RPD for 90 seconds and 10 ml of mouth rinse for swished around the mouth for 1 minute. Participants applied all these products topically orally twice daily (morning and evening) for 12 weeks.
|
Non-intervention Group
n=25 Participants
Participants did not receive any products and continued with their existing dental/denture hygiene practices and were instructed not to make changes to either their established habits or to the products they use following screening.
|
|---|---|---|
|
Mean Modified Gingival Index (MGI) at Week 6 and Week 12
Week 6
|
1.52 Score on a scale
Standard Error 0.044
|
1.92 Score on a scale
Standard Error 0.043
|
|
Mean Modified Gingival Index (MGI) at Week 6 and Week 12
Week 12
|
1.50 Score on a scale
Standard Error 0.039
|
1.86 Score on a scale
Standard Error 0.038
|
SECONDARY outcome
Timeframe: Week 6 and Week 12Population: mITT Population.
Supra-gingival plaque was assessed on the facial and lingual/palatal surfaces of all scorable teeth, six sites per tooth using TPI which indicated plaque accumulation in the gingival area of the tooth. Each tooth surface was divided into 3 areas; three scores were recorded facially (mesiofacial, facial, distofacial) and three scores lingually (mesiolin-gual, lingual and distolingual) generating a total of six scores per tooth. The plaque was disclosed and scored on a 6-point scale ranged from 0 to 5 where: 0=No plaque, 1=Separate flecks of plaque at the cervical margin, 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin, 3=Band of plaque wider than 1 mm but covering less than (\<) 1/3 of the tooth surface, 4=Plaque covering greater than or equal to (\>=) 1/3 but \< 2/3 of the tooth surface, 5=Plaque covering \>= 2/3 of the tooth surface. Higher score indicates worst outcome.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Participants were instructed to use a dentifrice containing 0.454% w/w stannous fluoride, COREGA denture foaming cleanser and mouth rinse containing 90 ppm sodium fluoride. Participants brushed with a strip of the dentifrice (full brush head) applied to the full length of the toothbrush head for 2 minutes followed by 2 pumps of denture cleanser foam brushed onto RPD for 90 seconds and 10 ml of mouth rinse for swished around the mouth for 1 minute. Participants applied all these products topically orally twice daily (morning and evening) for 12 weeks.
|
Non-intervention Group
n=25 Participants
Participants did not receive any products and continued with their existing dental/denture hygiene practices and were instructed not to make changes to either their established habits or to the products they use following screening.
|
|---|---|---|
|
Mean Overall Turesky Plaque Index (TPI) at Week 6 and Week 12
Week 6
|
2.12 Score on a scale
Standard Error 0.102
|
2.97 Score on a scale
Standard Error 0.098
|
|
Mean Overall Turesky Plaque Index (TPI) at Week 6 and Week 12
Week 12
|
2.07 Score on a scale
Standard Error 0.100
|
3.02 Score on a scale
Standard Error 0.096
|
SECONDARY outcome
Timeframe: Week 6 and Week 12Population: mITT Population.
Supra-gingival plaque was assessed on the facial and lingual/palatal surfaces of all scorable teeth, six sites per tooth using TPI which indicated plaque accumulation in the gingival area of the tooth. Each tooth surface was divided into 3 areas; three scores were recorded facially (mesiofacial, facial, distofacial) and three scores lingually (mesiolin-gual, lingual and distolingual) generating a total of six scores per tooth. The plaque was disclosed and scored on a 6-point scale ranging from 0 to 5, where 0=No plaque, 1=Separate flecks of plaque at the cervical margin, 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin, 3=Band of plaque wider than 1 mm but covering \< 1/3 of the tooth surface, 4=Plaque covering \>= 1/3 but \< 2/3 of the tooth surface, 5=Plaque covering \>= 2/3 of the tooth surface. Higher score indicates worst outcome.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Participants were instructed to use a dentifrice containing 0.454% w/w stannous fluoride, COREGA denture foaming cleanser and mouth rinse containing 90 ppm sodium fluoride. Participants brushed with a strip of the dentifrice (full brush head) applied to the full length of the toothbrush head for 2 minutes followed by 2 pumps of denture cleanser foam brushed onto RPD for 90 seconds and 10 ml of mouth rinse for swished around the mouth for 1 minute. Participants applied all these products topically orally twice daily (morning and evening) for 12 weeks.
|
Non-intervention Group
n=25 Participants
Participants did not receive any products and continued with their existing dental/denture hygiene practices and were instructed not to make changes to either their established habits or to the products they use following screening.
|
|---|---|---|
|
Mean Interproximal TPI at Week 6 and Week 12
Week 6
|
2.31 Score on a scale
Standard Error 0.108
|
3.22 Score on a scale
Standard Error 0.104
|
|
Mean Interproximal TPI at Week 6 and Week 12
Week 12
|
2.24 Score on a scale
Standard Error 0.111
|
3.29 Score on a scale
Standard Error 0.106
|
SECONDARY outcome
Timeframe: Week 6Population: mITT Population.
The BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. To perform the assessment, a probe was inserted into the gingival crevice to a depth of approximately 1 mm and then run around the tooth (at approximately 60 degrees to the long axis of the tooth) gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Three scores were recorded bucally/labially (distal, body, mesial sites) and 3 scores lingually/palatally (distal, body, mesial sites). All scorable teeth in 1 quadrant were probed first (approximately 30 seconds) before recording the number of gingival units which bled. The BI scoring included 3-point scale ranged from 0 to 2, where 0=no bleeding, 1=bleeding within 30 seconds of probing, 2=bleeding immediately on probing. Sites with a score of 1 or 2 were classified as 'bleeding' sites. Higher score indicates worst outcome.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Participants were instructed to use a dentifrice containing 0.454% w/w stannous fluoride, COREGA denture foaming cleanser and mouth rinse containing 90 ppm sodium fluoride. Participants brushed with a strip of the dentifrice (full brush head) applied to the full length of the toothbrush head for 2 minutes followed by 2 pumps of denture cleanser foam brushed onto RPD for 90 seconds and 10 ml of mouth rinse for swished around the mouth for 1 minute. Participants applied all these products topically orally twice daily (morning and evening) for 12 weeks.
|
Non-intervention Group
n=25 Participants
Participants did not receive any products and continued with their existing dental/denture hygiene practices and were instructed not to make changes to either their established habits or to the products they use following screening.
|
|---|---|---|
|
Mean BI at Week 6
|
0.45 Score on a scale
Standard Error 0.033
|
0.76 Score on a scale
Standard Error 0.031
|
SECONDARY outcome
Timeframe: Week 6 and Week 12Population: mITT Population.
The cleanliness of the partial denture was evaluated based on the modification of the Clinical Categorization of Denture Cleanliness Index. A suitable dental probe was used to gently scrape the surfaces of the RPD and the PDCI was scored. All surfaces of the RPD were assessed and the highest score applicable was recorded. PDCI scoring system included 5-point scale ranged from 0 to 4, where 0=No visible plaque; no matter adherent to the dental probe on light scraping, 1=No visible plaque; matter adherent to the dental probe on light scraping, 2=Deposits of plaque just visible on careful examination without need to confirm by scraping, 3=Deposits of plaque clearly visible, 4=Gross plaque deposits ("velvet appearance"). Higher score indicates worst outcome.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Participants were instructed to use a dentifrice containing 0.454% w/w stannous fluoride, COREGA denture foaming cleanser and mouth rinse containing 90 ppm sodium fluoride. Participants brushed with a strip of the dentifrice (full brush head) applied to the full length of the toothbrush head for 2 minutes followed by 2 pumps of denture cleanser foam brushed onto RPD for 90 seconds and 10 ml of mouth rinse for swished around the mouth for 1 minute. Participants applied all these products topically orally twice daily (morning and evening) for 12 weeks.
|
Non-intervention Group
n=25 Participants
Participants did not receive any products and continued with their existing dental/denture hygiene practices and were instructed not to make changes to either their established habits or to the products they use following screening.
|
|---|---|---|
|
Mean Partial Denture Cleanliness Index (PDCI) at Week 6 and 12
Week 6
|
1.2 Score on a scale
Standard Error 0.12
|
1.7 Score on a scale
Standard Error 0.12
|
|
Mean Partial Denture Cleanliness Index (PDCI) at Week 6 and 12
Week 12
|
1.1 Score on a scale
Standard Error 0.11
|
1.9 Score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Week 6 and Week 12Population: mITT Population.
The extent of calculus on each tooth surface (buccal and lingual) was determined by visual examination. Only definite deposits of hard calculus were recorded. The CI was assessed on the facial and lingual surfaces of each scorable tooth. The CI for each participant was calculated as the mean score of all tooth surfaces (facial/lingual). CI scoring included 4-point scale ranged from 0 to 3 where: 0=No calculus present, 1=Supragingival calculus covering not greater than (\>) 1/3 of exposed tooth surface, 2=Supragingival calculus covering \> 1/3 but not \> 2/3 of exposed tooth surface or presence of individual flecks of Subgingival calculus around cervical portion of tooth or both, 3= supragingival calculus covering \> 2/3 of exposed tooth surface or a continuous band of Subgingival calculus around cervical portion of tooth or both. Higher score indicates worst outcome.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Participants were instructed to use a dentifrice containing 0.454% w/w stannous fluoride, COREGA denture foaming cleanser and mouth rinse containing 90 ppm sodium fluoride. Participants brushed with a strip of the dentifrice (full brush head) applied to the full length of the toothbrush head for 2 minutes followed by 2 pumps of denture cleanser foam brushed onto RPD for 90 seconds and 10 ml of mouth rinse for swished around the mouth for 1 minute. Participants applied all these products topically orally twice daily (morning and evening) for 12 weeks.
|
Non-intervention Group
n=25 Participants
Participants did not receive any products and continued with their existing dental/denture hygiene practices and were instructed not to make changes to either their established habits or to the products they use following screening.
|
|---|---|---|
|
Mean Calculus Index (CI) at Week 6 and Week 12
Week 6
|
0.08 Score on a scale
Standard Error 0.036
|
0.19 Score on a scale
Standard Error 0.034
|
|
Mean Calculus Index (CI) at Week 6 and Week 12
Week 12
|
0.10 Score on a scale
Standard Error 0.024
|
0.18 Score on a scale
Standard Error 0.023
|
SECONDARY outcome
Timeframe: Week 6 and Week 12Population: mITT Population.
The extent of oral debris (defined as soft foreign matter on the surface of teeth) on each tooth surface was determined by running the side of a number 5 explorer (Shephard's crook) probe along the buccal, labial and lingual surfaces and noting the occlusal or incisal extent of the debris as it was removed from the tooth surface. The ODI was assessed on the facial and lingual surfaces of each scorable tooth. The ODI for each participant was calculated as the mean score of all tooth surfaces (facial/lingual).ODI scoring system included 4-point scale ranged from 0 to 3 where: 0=No debris or stain present, 1=Soft debris covering not \> 1/3 of the tooth surface the presence of extrinsic stains without other debris regardless of surface area covered, 2= Soft debris covering more than one third, but not more than two thirds, of the exposed tooth surface, 3=Soft debris covering more than two thirds of the exposed tooth surface. Higher score indicates worst outcome.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Participants were instructed to use a dentifrice containing 0.454% w/w stannous fluoride, COREGA denture foaming cleanser and mouth rinse containing 90 ppm sodium fluoride. Participants brushed with a strip of the dentifrice (full brush head) applied to the full length of the toothbrush head for 2 minutes followed by 2 pumps of denture cleanser foam brushed onto RPD for 90 seconds and 10 ml of mouth rinse for swished around the mouth for 1 minute. Participants applied all these products topically orally twice daily (morning and evening) for 12 weeks.
|
Non-intervention Group
n=25 Participants
Participants did not receive any products and continued with their existing dental/denture hygiene practices and were instructed not to make changes to either their established habits or to the products they use following screening.
|
|---|---|---|
|
Mean Oral Debris Index (ODI) at Week 6 and Week 12
Week 6
|
0.22 Score on a scale
Standard Error 0.054
|
0.50 Score on a scale
Standard Error 0.052
|
|
Mean Oral Debris Index (ODI) at Week 6 and Week 12
Week 12
|
0.20 Score on a scale
Standard Error 0.052
|
0.46 Score on a scale
Standard Error 0.050
|
SECONDARY outcome
Timeframe: Week 6 and Week 12Population: mITT Population.
OHI was calculated as sum score of mean CI and mean ODI. CI scoring:0=no calculus present,1=supragingival calculus covering not \>1/3 of exposed tooth surface,2=supragingival calculus covering \>1/3 but not \>2/3 of exposed tooth surface/presence of individual flecks of subgingival calculus around cervical portion of tooth/both,3=supragingival calculus covering \>2/3 of exposed tooth surface/continuous band of subgingival calculus around cervical portion of tooth/both. ODI scoring:0=no debris/stain present,1= supragingival calculus covering not \>1/3 of exposed tooth surface,2=supragingival calculus covering\>1/3 but not \>2/3 of exposed tooth surface/presence of individual flecks of subgingival calculus around cervical portion of tooth/both,3=supragingival calculus covering \>2/3 of exposed tooth surface/continuous band of subgingival calculus around cervical portion of tooth/ both. Thus, total OHI score range was 0 to 6. Higher score indicates worst outcome.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Participants were instructed to use a dentifrice containing 0.454% w/w stannous fluoride, COREGA denture foaming cleanser and mouth rinse containing 90 ppm sodium fluoride. Participants brushed with a strip of the dentifrice (full brush head) applied to the full length of the toothbrush head for 2 minutes followed by 2 pumps of denture cleanser foam brushed onto RPD for 90 seconds and 10 ml of mouth rinse for swished around the mouth for 1 minute. Participants applied all these products topically orally twice daily (morning and evening) for 12 weeks.
|
Non-intervention Group
n=25 Participants
Participants did not receive any products and continued with their existing dental/denture hygiene practices and were instructed not to make changes to either their established habits or to the products they use following screening.
|
|---|---|---|
|
Mean Oral Hygiene Index (OHI) at Week 6 and Week 12
Week 6
|
0.30 Score on a scale
Standard Error 0.085
|
0.69 Score on a scale
Standard Error 0.081
|
|
Mean Oral Hygiene Index (OHI) at Week 6 and Week 12
Week 12
|
0.30 Score on a scale
Standard Error 0.065
|
0.64 Score on a scale
Standard Error 0.062
|
Adverse Events
Intervention Group
Non-intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=24 participants at risk
Participants were instructed to use a dentifrice containing 0.454% w/w stannous fluoride, COREGA denture foaming cleanser and mouth rinse containing 90 ppm sodium fluoride. Participants brushed with a strip of the dentifrice (full brush head) applied to the full length of the toothbrush head for 2 minutes followed by 2 pumps of denture cleanser foam brushed onto RPD for 90 seconds and 10 ml of mouth rinse for swished around the mouth for 1 minute. Participants applied all these products topically orally twice daily (morning and evening) for 12 weeks.
|
Non-intervention Group
n=25 participants at risk
Participants did not receive any products and continued with their existing dental/denture hygiene practices and were instructed not to make changes to either their established habits or to the products they use following screening.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
4.2%
1/24 • All adverse events (AEs), and therefore all serious AEs (SAEs) were collected immediately after a participant consent to participate in the study until 5 days following last administration of the study product (or last procedure) (Up to Week12).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study product including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious.
|
0.00%
0/25 • All adverse events (AEs), and therefore all serious AEs (SAEs) were collected immediately after a participant consent to participate in the study until 5 days following last administration of the study product (or last procedure) (Up to Week12).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study product including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious.
|
|
Infections and infestations
Lower respiratory tract infection
|
4.2%
1/24 • All adverse events (AEs), and therefore all serious AEs (SAEs) were collected immediately after a participant consent to participate in the study until 5 days following last administration of the study product (or last procedure) (Up to Week12).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study product including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious.
|
0.00%
0/25 • All adverse events (AEs), and therefore all serious AEs (SAEs) were collected immediately after a participant consent to participate in the study until 5 days following last administration of the study product (or last procedure) (Up to Week12).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study product including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious.
|
|
Injury, poisoning and procedural complications
Burn oral cavity
|
4.2%
1/24 • All adverse events (AEs), and therefore all serious AEs (SAEs) were collected immediately after a participant consent to participate in the study until 5 days following last administration of the study product (or last procedure) (Up to Week12).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study product including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious.
|
0.00%
0/25 • All adverse events (AEs), and therefore all serious AEs (SAEs) were collected immediately after a participant consent to participate in the study until 5 days following last administration of the study product (or last procedure) (Up to Week12).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study product including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
4.2%
1/24 • All adverse events (AEs), and therefore all serious AEs (SAEs) were collected immediately after a participant consent to participate in the study until 5 days following last administration of the study product (or last procedure) (Up to Week12).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study product including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious.
|
0.00%
0/25 • All adverse events (AEs), and therefore all serious AEs (SAEs) were collected immediately after a participant consent to participate in the study until 5 days following last administration of the study product (or last procedure) (Up to Week12).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study product including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious.
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • All adverse events (AEs), and therefore all serious AEs (SAEs) were collected immediately after a participant consent to participate in the study until 5 days following last administration of the study product (or last procedure) (Up to Week12).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study product including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious.
|
0.00%
0/25 • All adverse events (AEs), and therefore all serious AEs (SAEs) were collected immediately after a participant consent to participate in the study until 5 days following last administration of the study product (or last procedure) (Up to Week12).
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study product including any washout or lead-in product (or medical device). A SAE is a particular category of an adverse event where the adverse outcome is serious.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER