NCT01224158

Study of an Experimental Toothbrush for Treatment and Prevention of Gingivitis

Completed NA Results posted Last updated 4 December 2019

What this trial tests

NA trial testing Experimental Power Toothbrush in Dental Devices, Home Care in 153 participants. Completed in 29 October 2010.

Timeline

13 September 2010

Primary endpoint
29 October 2010

29 October 2010

Quick facts

Lead sponsor	Johnson & Johnson Consumer and Personal Products Worldwide
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	153
Start date	13 September 2010
Primary completion	29 October 2010
Estimated completion	29 October 2010
Sites	1 location across United States

Drugs / interventions tested

• Experimental Power Toothbrush
• Flat trimmed Manual Toothbrush

Conditions studied

• Dental Devices, Home Care — all drugs for Dental Devices, Home Care →

Sponsor

Johnson & Johnson Consumer and Personal Products Worldwide — full company profile →

Who can join

18 and older, any sex, with Dental Devices, Home Care. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 42 Primary · Day 42

Gingivitis was assessed by the Modified Gingival Index on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth by the dental examiner using following scale score range from 0 to 4, where 0 - Normal (absence of inflammation); 1 - Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit; 2 - Mild inflammation of the entire gingival unit; 3 - Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 - Severe inflammation (marked redness and edema/hypertrophy, spontaneous bl

Group	Value	95% CI
Manual Toothbrush (PR-000172)	1.880	± 0.1223
Power Toothbrush (PR-009577)	1.770	± 0.1443

Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 28 Secondary · Day 28

Gingivitis was assessed by the Modified Gingival Index on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth by the dental examiner using following scale with score range from 0 to 4, where 0 - Normal (absence of inflammation); 1 - Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit; 2 - Mild inflammation of the entire gingival unit; 3 - Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 - Severe inflammation (marked redness and edema/hypertrophy, spontaneo

Group	Value	95% CI
Manual Toothbrush (PR-000172)	1.957	± 0.1225
Power Toothbrush (PR-009577)	1.868	± 0.1287

Whole-mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 42 Secondary · Day 42

Supra-gingival plaque was assessed on the facial and lingual surfaces of the teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per tooth: A-C along the gingival margin; D and F (inter-proximal zones) directly above A-C; G-H across the middle of the tooth and I covers the incisal area. Plaque was assigned on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth. Mean RMNPI overall was calculated for each participant as the tot

Group	Value	95% CI
Manual Toothbrush (PR-000172)	0.146	± 0.0710
Power Toothbrush (PR-009577)	0.131	± 0.0633

Whole-Mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 28 Secondary · Day 28

Supra-gingival plaque was assessed on the facial and lingual surfaces of the teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per tooth: A-C along the gingival margin; D and F (inter-proximal zones) directly above A-C; G-H across the middle of the tooth and I covers the incisal area. Plaque was assigned on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth. Mean RMNPI overall was calculated for each participant as the tot

Group	Value	95% CI
Manual Toothbrush (PR-000172)	0.164	± 0.0755
Power Toothbrush (PR-009577)	0.148	± 0.0762

Hard-to-reach Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 Secondary · Day 28 and 42

Hard-to-reach mean score is defined as mean of scores over following areas combined; a) Gingival margin (Sites A - C); b) Distal Molars (F for teeth 2, 15, 18, and 31 or the most posterior molar in that quadrant); c) Lingual of the mandibular incisors (Teeth 23-26, lingual); d) Interproximal (Sites D and F); e) Mandibular posterior lingual (Teeth 18-21, 28-31, lingual). Supra-gingival plaque was assessed on facial and lingual surfaces of teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per tooth:

Day 28

Group	Value	95% CI
Manual Toothbrush (PR-000172)	0.232	± 0.1066
Power Toothbrush (PR-009577)	0.209	± 0.1067

Day 42

Group	Value	95% CI
Manual Toothbrush (PR-000172)	0.208	± 0.0993
Power Toothbrush (PR-009577)	0.186	± 0.0905

Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area Secondary · Day 28 and 42

Hard-to-reach mean score is defined as mean of scores over following areas separately d; a) Gingival margin (Sites A - C); b) Distal Molars (F for teeth 2, 15, 18, and 31 or the most posterior molar in that quadrant); c) Lingual of the mandibular incisors (Teeth 23-26, lingual); d) Interproximal (Sites D and F); e) Mandibular posterior lingual (Teeth 18-21, 28-31, lingual). Supra-gingival plaque was assessed on facial and lingual surfaces of teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per to

Gingival Margin: Day 28

Group	Value	95% CI
Manual Toothbrush (PR-000172)	0.298	± 0.1172
Power Toothbrush (PR-009577)	0.271	± 0.1169

Gingival Margin: Day 42

Group	Value	95% CI
Manual Toothbrush (PR-000172)	0.273	± 0.1181
Power Toothbrush (PR-009577)	0.246	± 0.0992

Distal Molars: Day 28

Group	Value	95% CI
Manual Toothbrush (PR-000172)	0.413	± 0.2599
Power Toothbrush (PR-009577)	0.399	± 0.2175

Distal Molars: Day 42

Group	Value	95% CI
Manual Toothbrush (PR-000172)	0.352	± 0.2172
Power Toothbrush (PR-009577)	0.339	± 0.2284

Lingual of the Mandibular Incisors: Day 28

Group	Value	95% CI
Manual Toothbrush (PR-000172)	0.190	± 0.2501
Power Toothbrush (PR-009577)	0.149	± 0.2430

Lingual of the Mandibular Incisors: Day 42

Group	Value	95% CI
Manual Toothbrush (PR-000172)	0.152	± 0.1892
Power Toothbrush (PR-009577)	0.119	± 0.2035

Interproximal: Day 28

Group	Value	95% CI
Manual Toothbrush (PR-000172)	0.195	± 0.1173
Power Toothbrush (PR-009577)	0.169	± 0.1122

Interproximal: Day 42

Group	Value	95% CI
Manual Toothbrush (PR-000172)	0.171	± 0.1047
Power Toothbrush (PR-009577)	0.148	± 0.1054

Sponsor's own description

This study is 6 weeks long with 6 visits to a clinical site. People participating in this study will be asked to brush their teeth two times a day with a provided toothbrush. For one of those six weeks people will be asked to rinse with a mouthwash. During that time, people will use the mouthwash two times a day and will not be allowed to brush their teeth at all. The mouth, teeth, tongue and gums will be looked at by a dentist. At each visit, people will rinse with a pink liquid that will dye their mouths pink. The dye is temporary and will go away by the end of the day. They may also be asked to complete a short questionnaire about their experience.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.