Periodontal Inflammation Clinical Trial
Official title:
Effects of Genius Toothbrushes on Periodontal Status of Patients Undergoing Fixed Orthodontic Treatment
Verified date | January 2020 |
Source | Pamukkale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the effects of genius toothbrushes on periodontal status of patients during fixed orthodontic treatment.Half of the patients received manual orthodontic toothbrushes (Oral B Ortho, Procter & Gamble, USA) with V-shaped bristles and rounded ends. The others received genius orthodontic toothbrush (Oral B Genius 8900, Procter & Gamble, USA) with Oral-B CrossAction brush head, Procter & Gamble, USA).
Status | Completed |
Enrollment | 36 |
Est. completion date | March 28, 2019 |
Est. primary completion date | February 28, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Permanent dentition with no missing teeth - No systemic or severe periodontal problems - Indication of non-extraction fixed orthodontic treatment - No use of drugs in the past two months - Absence of physical problems that prevent brushing - Right handedness for brushing - Same bracket type (0.022 slot metal, conventional) and ligation technique (wire ligature) - Finishing of leveling phase (use of rectangular wires) - Initial total score was between 3 and 10 for the labial surface of each tooth according to the modified Silness and Löe plaque index Exclusion Criteria: - Missing teeth - Systemic or severe periodontal problem - Indication of extraction treatment - Use of drugs in the past two months - Levelling phase of fixed orthodontic treatment |
Country | Name | City | State |
---|---|---|---|
Turkey | Pamukkale University Faculty of Dentistry Department of Orthodontics | Deni?zli? |
Lead Sponsor | Collaborator |
---|---|
Pamukkale University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Löe and Silness gingival index measurement | A score from 0 to 3 is given. Grade 0 indicates normal gingiva; grade 1 mild inflammation with no bleeding; grade 2 moderate inflammation, erythema, swelling, bleeding on probing or when pressure applied; grade 3 severe inflammation, severe erythema and swelling, tendency toward spontaneous hemorrhage, some ulceration | 1 month | |
Primary | Löe and Silness gingival index measurement | A score from 0 to 3 is given. Grade 0 indicates normal gingiva; grade 1 mild inflammation with no bleeding; grade 2 moderate inflammation, erythema, swelling, bleeding on probing or when pressure applied; grade 3 severe inflammation, severe erythema and swelling, tendency toward spontaneous hemorrhage, some ulceration | 2 months | |
Primary | Löe and Silness gingival index measurement | A score from 0 to 3 is given. Grade 0 indicates normal gingiva; grade 1 mild inflammation with no bleeding; grade 2 moderate inflammation, erythema, swelling, bleeding on probing or when pressure applied; grade 3 severe inflammation, severe erythema and swelling, tendency toward spontaneous hemorrhage, some ulceration | 4 months | |
Primary | Modified Silness and Löe plaque index measurement | The buccal surface of each tooth is divided into four zones (mesial, distal, gingival and incisal) to the bracket. Each of the four sites of the buccal tooth surface is given a score from 0 to 3, where 0 indicates the absence of plaque; 1 indicates no plaque visible, but an accumulation of soft deposit on a probe when used to clean the surface; 2 indicates a moderate accumulation of soft deposit on the tooth which can be seen with the naked eye; and 3 indicates an abundance of soft matter on the tooth. For the analysis, values are summed to obtain a total score per participant. | 1 month | |
Primary | Modified Silness and Löe plaque index measurement | The buccal surface of each tooth is divided into four zones (mesial, distal, gingival and incisal) to the bracket. Each of the four sites of the buccal tooth surface is given a score from 0 to 3, where 0 indicates the absence of plaque; 1 indicates no plaque visible, but an accumulation of soft deposit on a probe when used to clean the surface; 2 indicates a moderate accumulation of soft deposit on the tooth which can be seen with the naked eye; and 3 indicates an abundance of soft matter on the tooth. For the analysis, values are summed to obtain a total score per participant. | 2 months | |
Primary | Modified Silness and Löe plaque index measurement | The buccal surface of each tooth is divided into four zones (mesial, distal, gingival and incisal) to the bracket. Each of the four sites of the buccal tooth surface is given a score from 0 to 3, where 0 indicates the absence of plaque; 1 indicates no plaque visible, but an accumulation of soft deposit on a probe when used to clean the surface; 2 indicates a moderate accumulation of soft deposit on the tooth which can be seen with the naked eye; and 3 indicates an abundance of soft matter on the tooth. For the analysis, values are summed to obtain a total score per participant. | 4 months | |
Primary | Bleeding on probing scores | A periodontal probe runs along the marginal gingiva at an angle of approximately 60° to the longitudinal axis of the tooth to determine whether probing elicited marginal bleeding (score 1) or not (score 0). The inflammation was recorded as bleeding scores if bleeding occurred within 30 seconds of probing. Bleeding on probing was estimated as a percentage. | 1 month | |
Primary | Bleeding on probing scores | A periodontal probe runs along the marginal gingiva at an angle of approximately 60° to the longitudinal axis of the tooth to determine whether probing elicited marginal bleeding (score 1) or not (score 0). The inflammation was recorded as bleeding scores if bleeding occurred within 30 seconds of probing. Bleeding on probing was estimated as a percentage. | 2 months | |
Primary | Bleeding on probing scores | A periodontal probe runs along the marginal gingiva at an angle of approximately 60° to the longitudinal axis of the tooth to determine whether probing elicited marginal bleeding (score 1) or not (score 0). The inflammation was recorded as bleeding scores if bleeding occurred within 30 seconds of probing. Bleeding on probing was estimated as a percentage. | 4 months |
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