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Comparison of the effect of dental bleaching with carbamide peroxide 15% and carbamide peroxide 20% on periodontal health

Protocol summary

Study aim
Comparison of the effect of dental bleaching with carbamide peroxide 15% and carbamide peroxide 20% on periodontal health
Design
A randomized single-blinded clinical trial with parallel groups including two intervention groups and one control group.
Settings and conduct
Dental bleaching may damage periodontal tissues. This single-blinded clinical trial was conducted at a private office in Ahvaz. 45 volunteers were divided to three groups (n=15) according to bleaching agent: Intervention group 1 (carbamide peroxide 15%), Intervention group 2 (carbamide peroxide 20%), and control group (placebo). After administration of the agents for 8 hours/night for 6 nights, plaque index, gingival index and bleeding on probing were evaluated at four time points (baseline, 7th, 14th and 21th day after dental bleaching).
Participants/Inclusion and exclusion criteria
Inclusion criteria: need for dental bleaching, general health, aged 20 to 40 years, having at least 12 teeth from 3 to 14, agree to participate and fulfill the study phase; Exclusion criteria: oral diseases, systemic diseases, Allergic to dental bleaching agents, the presence of crown and extensive composite restoration in the teeth receiving dental bleaching.
Intervention groups
Intervention group 1: dental bleaching with carbamide peroxide 15% (Ultradent, USA) for 8 hours ) 8 hours/night for 6 nights. Intervention group 2: dental bleaching with carbamide peroxide 20% (Ultradent, USA) 8 hours/night for 6 nights, Control group: Using anti-allergic gel (Ultradent, USA) as placebo 8 hours/night for 6 nights
Main outcome variables
Plaque index (PI), gingival index (GI) and bleeding on probing (BOP)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190509043541N2
Registration date: 2019-06-30, 1398/04/09
Registration timing: retrospective

Last update: 2019-06-30, 1398/04/09
Update count: 0
Registration date
2019-06-30, 1398/04/09
Registrant information
Name
Azarnoush Aryankia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 4565
Email address
aryankian-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2019-03-03, 1397/12/12
Actual recruitment start date
2018-04-09, 1397/01/20
Actual recruitment end date
2019-03-03, 1397/12/12
Trial completion date
2019-04-09, 1398/01/20
Scientific title
Comparison of the effect of dental bleaching with carbamide peroxide 15% and carbamide peroxide 20% on periodontal health
Public title
Effect of dental bleaching on periodontal health
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Need to bleach teeth General health Aged 20 to 40 years Having at least 12 teeth from 3 to 14 Agree to participate and fulfill the study phase
Exclusion criteria:
Oral diseases Systemic diseases Allergy to bleaching agents The presence of crown and extensive composite restoration in the teeth receiving dental bleaching
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Using random number table including numbers 1-45: numbers 1-15, 16-30 and 31-45 were assigned for intervention group 1 (carbamide peroxide 15%), intervention group 2 (carbamide peroxide 20%) and control group (placebo), respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcomes evaluator was kept blind to the type of substances used as bleaching agent or placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
5618985991
Approval date
2018-06-10, 1397/03/20
Ethics committee reference number
IR.AJUMS.REC.1397.960

Health conditions studied

1

Description of health condition studied
Periodontal health
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Plaque index
Timepoint
At the beginning of the study (before the intervention), and days 7, 9 and 21 after intervention fulfillment
Method of measurement
Clinical by Loe and Silness plaque index

2

Description
Gingival index
Timepoint
At the beginning of the study (before the intervention), and days 7, 9 and 21 after intervention fulfillment
Method of measurement
Clinical by Loe and Silness gingival index

3

Description
Bleeding on probing
Timepoint
At the beginning of the study (before the intervention), and days 7, 9 and 21 after intervention fulfillment
Method of measurement
Periodontal probe

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: dental bleaching with carbamide peroxide 15% (Ultradent, USA) for 8 hours/night for 6 nights
Category
Treatment - Other

2

Description
Intervention group 2: dental bleaching with carbamide peroxide 20% (Ultradent, USA) for 8 hours/night for 6 nights
Category
Treatment - Other

3

Description
Control group: Using anti-allergic gel (Ultradent, USA) as placebo 8 hours/night for 6 nights
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Azadeh Ghaemi dental office
Full name of responsible person
Dr. Azadeh Ghaemi
Street address
No.6, Farabi, 5 West Ave., Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155884654
Phone
+98 61 3338 3940
Email
azadehghaemi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
badavi-m@ajums.ac.ir
Grant name
Ahvaz University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Azarnoush Aryankia
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Periodontology Department, Dental College, Jundishapur University of Medical Sciences, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 613332368
Email
aryankian-a@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Azarnoush Aryankia
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Periodontology Department, Dental College, Jundishapur University of Medical Sciences, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3333 2368
Email
aryankian-a@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Azarnoush Aryankia
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Periodontology Department, Dental College, Jundishapur University of Medical Sciences, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3333 2368
Email
aryankian-a@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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