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Assessment Of Propolis, Dentin Bonding Agent And Placebo In Reducing Dentinal Hypersensity, In Hypersensitive Teeth Subsequent Of Periodontal Surgeries: A Randomized Clinical Trial

Protocol summary

Summary
Objectives:This randomized clinical trial study was aimed to evaluate the effect of two desensitizing agents on reduction of Dentin Hypersensivity(DH) subsequent of periodontal surgeries. Design: A sample of 120 teeth from 96 patients, among which maximum 2 teeth had DH, was randomly allocated into 4 treatment groups: Group 1 treated with 10% ethanolic extract of Propolis, Group 2 treated with 30% ethanolic extract of Propolis, Group 3 treated with dentin bonding agent and Group 4 with Distilled water (placebo). In patients with one hypersensitive tooth, Randomization was performed for the first 12 patients with 12 opaque envelopes that containing 3 cards stipulating ‘Dentin bonding agent, ’ 3 cards ‘Propolis 10%’, 3 cards ‘Propolis 30%’ and 3 envelopes containing 3 cards stipulating ‘Distilled water’ (block randomization). After the first 12 patients, the randomization process was repeated until 4 groups were completed. But, patients with two hypersensitive teeth, were randomized by 4 opaque envelopes that containing 1 card stipulating ‘Dentin bonding agent’, 1 card ‘Propolis 10%’, 1 card ‘Propolis 30%’ and 1 envelope containing 1 card stipulating ‘Distilled water’. Setting and conduct: Visual Analogue Scale(VAS) was used to record the degree of hypersensivity, based on patientsʼ response to tactile and air blast stimuli. Pain response was evaluated before treatment and at 1,7,14,21,60 and 90-day intervals. Participants: Patients who had periodontal surgery in Department of Periodontology in Dentistry Collegial of Tehran University; With maximum 2 not adjacent caries-free teeth with dentinal hypersensivity at the cervical border. Exclusion Criteria: Teeth with dental caries, cracks or fractures in the cervical borders of the teeth;Teeth with any extensive and incorrect restorations,being of prostheses or orthodontic appliances; Patients with a history of use of any desensitizing agents. Intervention: In group which treated with dentin bonding agent, light cure LED with 400-550 mW/cm2 power used for 15 seconds. Also application of placebo(distilled water) recommended 2 times a day for 4 weeks. In groups 10% and 30% Propolis and Distilled water, placebo exposure was used after first application. So patients applied gel or distilled water in each group, 2 times a day for 4 weeks. variables: Degree of pain

General information

Acronym
D.DH
IRCT registration information
IRCT registration number: IRCT2016102430475N1
Registration date: 2016-11-18, 1395/08/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-18, 1395/08/28
Registrant information
Name
Mitra Askari
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5585 1131
Email address
m-askari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of Dentistry,Tehran University Of Medical Sciences
Expected recruitment start date
2016-01-07, 1394/10/17
Expected recruitment end date
2016-03-18, 1394/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment Of Propolis, Dentin Bonding Agent And Placebo In Reducing Dentinal Hypersensity, In Hypersensitive Teeth Subsequent Of Periodontal Surgeries: A Randomized Clinical Trial
Public title
Comparision of Two Dentinal Densitizing Agents
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients who had periodontal surgery in Department of Periodontology in Dentistry Collegial of Tehran University; Patients who had maximum 2 not adjacent caries-free teeth with dentinal hypersensitivity at the cervical border; Patients with adequate and good oral hygiene; Patients with complete general and physical health . Exclusion Criteria: Patients who has any systemic illnesses and/or psychological diseases, and previous hospitalization; Teeth with dental caries, cracks or fractures in the cervical borders of the teeth; Teeth with any extensive and incorrect restorations,being of prostheses or orthodontic appliances; Patients who were drug addicted and analgesic and/or anti-inflammatory drugs users; Patients with a history of use of any desensitizing agents.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Tehran University of Medical Science
Street address
Tehran University of Medical Science
City
Tehran
Postal code
Approval date
2016-01-05, 1394/10/15
Ethics committee reference number
IR.TUMS.REC.1394.1567

Health conditions studied

1

Description of health condition studied
Dentinal Hypersensitivity
ICD-10 code
k03.8
ICD-10 code description
Other specified diseases of hard tissues of teeth

Primary outcomes

1

Description
Dentinal Hypersensitivity
Timepoint
1,7,14,21,60 and 90-day
Method of measurement
Visual Analog Scale

Secondary outcomes

empty

Intervention groups

1

Description
In group which treated with' Dentin Bonding Agent', light cure LED with 400-550 mW/cm2 power used for 15 seconds. Also application of placebo(distilled water) recommended after drying and isolation of teeth by using disposable micro brush 2 times a day for 4 weeks. Treatment Evaluation Procedure: Each tooth received two stimuli: Air Blast and Tactile. The degree of hypersensivity was reported by Visual Analogue Scale(VAS), from 0 to 10, The values were collected before the intervention(baseline values) and after each applications, on days 1,7,14,21,60 and 90 respectively.
Category
Treatment - Other

2

Description
In group which treated with '10% Propolis', placebo exposure was used after first application. So patients applied gel after drying and isolation of teeth by using disposable micro brush 2 times a day for 4 weeks. Treatment Evaluation Procedure: Each tooth received two stimuli: Air Blast and Tactile. The degree of hypersensivity was reported by Visual Analogue Scale(VAS) in before the intervention(baseline values) and after each applications, on days 1,7,14,21,60 and 90 respectively.
Category
Treatment - Drugs

3

Description
In group which treated with '30% Propolis', placebo exposure was used after first application. So patients applied gel after drying and isolation of teeth by using disposable micro brush 2 times a day for 4 weeks. Treatment Evaluation Procedure: Each tooth received two stimuli: Air Blast and Tactile. The degree of hypersensivity was reported by Visual Analogue Scale(VAS) in before the intervention(baseline values) and after each applications, on days 1,7,14,21,60 and 90 respectively.
Category
Treatment - Drugs

4

Description
In group which treated with 'Distilled Wather', placebo exposure was used after first application. So patients applied Distilled Wather after drying and isolation of teeth by using disposable micro brush 2 times a day for 4 weeks. Treatment Evaluation Procedure: Each tooth received two stimuli: Air Blast and Tactile. The degree of hypersensivity was reported by Visual Analogue Scale(VAS) in before the intervention(baseline values) and after each applications, on days 1,7,14,21,60 and 90 respectively.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department Of Periodontology,Dentistry Faculty,Tehran University Of Medical Sciences
Full name of responsible person
Melia Zargar
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dentistry faculty,Tehran university of medical sciences
Full name of responsible person
Mitra Montazer
Street address
Dentistry Faculty Pardis, Mahan Street, Navab HighWay
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dentistry faculty,Tehran university 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
Dentistry faculty, Tehran University Of Medical Sciences
Full name of responsible person
Melika Zargar
Position
Student Of Dentistry
Other areas of specialty/work
Street address
Dentistry faculty. Tehran University Of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 5585 1131
Fax
Email
Zargar.Melika@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dentistry Faculty- Tehran University Of Medical Sciences
Full name of responsible person
Mitra Askari
Position
Assistant
Other areas of specialty/work
Street address
Amir Abad street, Dentistry Faculty- Tehran University Of Medical Sciences-Department of Maxillofacial Pathology
City
Tehran
Postal code
Phone
+98 21 5585 1131
Fax
Email
m-askari@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dentistry Faculty, Tehran University Of Medical Sciences
Full name of responsible person
Mitra Askari
Position
Assistant
Other areas of specialty/work
Street address
Amir Abad Street, Dentistry Faculty, Tehran University Of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 5585 1131
Fax
Email
M-askari@sina.tums.ac.ir
Web page address

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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