Comparative Evaluation of Manual Cross-action and Powered Cross-action Toothbrushes in Control of Plaque and Soft Tissue Inflammation Around Implants Supporting Mandibullar Overdentures.
This study was a cross over clinical trial to determine the efficacy of powered and manual toothbrush in the control of plaque and soft tissue inflammation around the mandibullar overdenture supporting implants. Samples involved 10 edentulous subject, aged 47-72 years, having removable mandibullar overdenture which supported by 2 unsplinted implant, and all of them were using maxillary complete denture. Study consisted of two 4-weeks periods that were separated by a 2-week interval as wash out phase. In each phase subjects were randomly assigned to one of the intervention groups (type of toothbrushes). 2 days prior to the start of each phase implants were polished. Plaque index and bleeding index before and after brushing were recorded. Data analyzed by SPSS software and with T-test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104054877N4
Registration date:2011-04-26, 1390/02/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-26, 1390/02/06
Registrant information
Name
Jaber Yaghini
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 1434 2136
Email address
j_yaghini@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Chancellery of Isfahan Faculty of Dentistry
Expected recruitment start date
2009-01-07, 1387/10/18
Expected recruitment end date
2009-07-27, 1388/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Evaluation of Manual Cross-action and Powered Cross-action Toothbrushes in Control of Plaque and Soft Tissue Inflammation Around Implants Supporting Mandibullar Overdentures.
Public title
Comparative Evaluation of Manual and Powered Toothbrushes in Control of Plaque and Soft Tissue Inflammation Around Implants Supporting Overdentures.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Is not smoker From 3 months before; using no antibiotic or antimicrobial mouthwash; Have not any medical problems such as soft tissue problems; Exclusion criteria; Use of other hygienic regimen except which researcher is explaining; and afflict to malady that needs use of antibiotics and affects soft tissue; lack of cooperation by the patient
Age
From 47 years old to 72 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Chancellery of Isfahan Faculty of Dentistry
Street address
Isfahan Faculty of Dentistry
City
Isfahan
Postal code
Approval date
2009-03-20, 1387/12/30
Ethics committee reference number
388113
Health conditions studied
1
Description of health condition studied
Mandibular Implants
ICD-10 code
Z96.5
ICD-10 code description
Presence of Tooth-root and Mandibular Implants
Primary outcomes
1
Description
Plaque Measurment
Timepoint
2weeks
Method of measurement
Modified Plaque Index
Secondary outcomes
1
Description
Bleeding Measurment
Timepoint
2weeks
Method of measurement
Modified Sulcus Bleeding Index
Intervention groups
1
Description
Use of Manual Cross-action Toothbrush
Category
Other
2
Description
Use of Power Cross-action Toothbrush
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Faculty of Dentistry
Full name of responsible person
Dr.Ahmad Moghareabed
Street address
Department of Periodontoly - Isfahan Faculty of Dentistry
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Chancellery of Isfahan Faculty of Dentistry
Full name of responsible person
Dr. Omid Savabi
Street address
Research Chancellery of Isfahan Faculty of Dentistry
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Chancellery of Isfahan Faculty of Dentistry
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan Faculty of Dentistry
Full name of responsible person
Dr.Jaber Yaghini
Position
Periodontologist-Assistant Professor
Other areas of specialty/work
Street address
Department of Periodontology-Isfahan Faculty of Dentistry
City
Isfahan
Postal code
Phone
+98 31 1792 2842
Fax
Email
J_Yaghini@dnt.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Faculty of Dentistry
Full name of responsible person
Dr.Ahmad Moghareabed
Position
Periodontologist-Associated Professor
Other areas of specialty/work
Street address
Isfahan Faculty of Dentistry-Department of Periodontology
City
Isfahan
Postal code
Phone
+98 31 1792 2842
Fax
Email
Moghareabed@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)