Protocol summary

Summary
The aim of this study is to compare the clinical performance of three different adhesive systems over a period of 18 months in noncarious Class V lesions. Thirty patients, male and female, (aged 20-50 years) with at least three noncarious cervical lesions were enrolled in the study. Subjects were healthy and without any systemic or periodontal disease. The selected teeth must have contact with opposite teeth without any high occlusion stress. Subjects with poor oral hygiene and under treatment with anti sensitivity materials excluded from the study. One operator placed ninety restorations in thirty patients. The teeth were restored randomly with one adhesive and manufacturers' instructions were followed. The deep of cervical lesion should not be more than 2 mm. The teeth were restored with three adhesive systems including; Opti Bond FL (total etch, three steps), Opti Bond Solo (total etch, two steps) and Opti Bond All-in-one (self etch, one-step) and then with Herculite (Kerr) resin composite. Thirty restorations were placed in cavities with no marginal bevels and no mechanical retentions for each adhesive system. The restorations are photographed at baseline and at recall periods. Patients will be recalled at 6, 12 and 18 months after intervention, and two examiner will evaluate the restorations using the USPHS criteria for color match, marginal discoloration, marginal adaptation, caries formation, anatomic form, postoperative sensitivity, surface roughness, and retention. Finally, the ranking of restorations will be done for three different studied adhesives from the standpoint of clinical performance in three recall evaluation times.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138709301509N1
Registration date: 2009-05-03, 1388/02/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-05-03, 1388/02/13
Registrant information
Name
Horieh Moosavi
Name of organization / entity
Dental School of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1869 1500
Email address
moosavih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
The Research Council of Mashhad and Tabriz University of Medical Sciences, Mashhad, Tabriz Iran.
Expected recruitment start date
2008-06-21, 1387/04/01
Expected recruitment end date
2008-11-21, 1387/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of three adhesive systems for the restoration of non-carious cervical lesions
Public title
Clinical evaluation of three adhesive systems for the restoration of non-carious cervical lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age 20 to 50 years, signing informed consent prior to commencement of any treatment, Presence of at least have three NCCLs, having contact with opposite teeth without any high occlusion stress for selected teeth, cavity cervical margins placed on cementum with no more than 50% put on enamel, assessable isolation and observable and easily accessible gingival margins during tooth restoration, Exclusion Criteria: Any systemic disease, any periodontal disease, history of periodontal surgery three months prior to study, poor oral hygiene, treatment with anti sensitivity materials such as desensitizer dentifrices, high-risk caries, cervical lesions with caries and restricted to the labial area with extending to proximal surfaces, cervical lesions with severe degree of sclerosis, presence of any caries or restorations except in cervical area of the tooth labial portion, the deep of cervical lesion more than 2 mm (probe measurement), depth of lesion more than usual that need to liner placement such as calcium hydroxide.
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
All restorations will be done by One operator. Two examiners will recall and examine the restorations.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Official Center of Mashhad university of Medical Sciences , University street.
City
Mashhad
Postal code
13131-91389
Approval date
2008-11-06, 1387/08/16
Ethics committee reference number
86470

Health conditions studied

1

Description of health condition studied
Noncarious cervical lesions
ICD-10 code
K03.1
ICD-10 code description
Abrasion of teeth

2

Description of health condition studied
Noncarious Cervical Lesions
ICD-10 code
K03.2
ICD-10 code description
Erosion of teeth

Primary outcomes

1

Description
Color match
Timepoint
Baseline, 6 month, 12 month and 18 month after first appointment
Method of measurement
Visual inspection with mirror at 45 cm and periodic photography

2

Description
Retention
Timepoint
Baseline, 6 months, 12 months and 18 months after intervention
Method of measurement
Visual inspection with explorer and mirror

Secondary outcomes

1

Description
Anatomic form
Timepoint
Baseline, 6 months, 12 months and 18 months after intervention
Method of measurement
Visual inspection with explorer and mirror, if needed

2

Description
Caries formation
Timepoint
Baseline, 6 months, 12 months and 18 months after intervention
Method of measurement
Visual inspection with explorer, mirror, radiographies, if needed

3

Description
Marginal adaptation
Timepoint
Baseline, 6 months, 12 months and 18 months after intervention
Method of measurement
Visual inspection with explorer and mirror, if needed

4

Description
Marginal discoloration
Timepoint
Baseline, 6 months, 12 months and 18 months after intervention
Method of measurement
Visual inspection with mirror at 45 cm

5

Description
Postoperative sensitivity
Timepoint
Baseline, 6 months, 12 months and 18 months after intervention
Method of measurement
Questioning the patients

6

Description
Surface roughness
Timepoint
Baseline, 6 months, 12 months and 18 months after intervention
Method of measurement
Visual inspection with explorer and mirror

Intervention groups

1

Description
Seventh Generation, One step, Optibond All-in-One (Kerr)
Category
Treatment - Other

2

Description
Fifth Generation, Total-etch, two step, OptiBond Solo (Kerr)
Category
Treatment - Other

3

Description
Fourth generation, total-etch, three steps, OptiBond FL(Kerr)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Mashhad Health Center and Mashhad Dental School
Full name of responsible person
Rajabali Khodadadi
Street address
No. 24, Faramarz abasi 25
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research, Mashhad and Tabriz Universities of Medical Sciences.
Full name of responsible person
Dr. Horieh Moosavi
Street address
No. 44, Daneshjo 24,Blv. Daneshjo, Blv. Vakil Abad.
City
Mashhad
Grant name
86470
Grant code / Reference number
86470
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Mashhad and Tabriz Universities of Medical Sciences.
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
Dental Research Center of Mashhad Dental School
Full name of responsible person
Dr. Horieh Moosavi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of operative dentistry, Dental School, Blv. Vakil Abad
City
Mashhad
Postal code
91735
Phone
+98 51 1882 9506
Fax
+98 51 1882 9500
Email
moosavih@mums.ac.ir or dentist_57@yahoo.com
Web page address
http://www.mums.ac.ir/dental/fa/moosavih

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental Research Center of Mashhad Dental School
Full name of responsible person
Dr. Horieh Moosavi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of operative dentistry, Dental School, Blv. Vakil Abad
City
Mashhad
Postal code
91735
Phone
+98 51 1882 9506
Fax
+98 51 1882 9500
Email
moosavi@mums.ac.ir or dentist_57@yahoo.com
Web page address
http://www.mums.ac.ir/dental/fa/moosavih

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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