Comparison of efficacy of hydrogen peroxide mouthwash with chlorhexidine on healing and pain after surgical removal of impacted mandibular third molars
Comparison of the effect of hydrogen peroxide mouthwash with chlorhexidine on the healing and pain after surgery of the mandibular third molars of patients referred to the surgical department of the School of Dentistry of Islamic Azad University of Tehran in 1400.
Design
Clinical trial with control group, with parallel groups, double-blind, non randomized, phase 3 on 62 patients.Patients who visit on even days of the week receive the first intervention and patients who visit on odd days receive the second intervention.
Settings and conduct
The patients will be divided into two groups of 31, case and control, by non randomized double blinding method. Before start the operation, 15 cc from one of the Nanosil® and chlorhexidine 0.2% Najho 250 mL would be for 1min to wash their mouths with it. The evaluation of the pain level with the help of VAS and the measurement of the recovery rate (healing)is carried out by the "wound’s healing process" scale.
Participants/Inclusion and exclusion criteria
Having a mandibular third molars with a surgery difficulty (A,B) (Pell and Gregory), having an age between 18-50 years, non smoker
Intervention groups
The patients were divided into two groups : 31case and 31control groups.
In case and control groups , before the onset of surgery , 15 cc of one of the patients with hydrogen peroxide Nanosil® and chlorhexidine Najho® 0.2% 250ml will be allocated to wash their mouth for one minute. The patients will be told to wash their mouth twice a day for a week after surgery with one of the hydrogen peroxide and chlorhexidine solutions for 30 seconds.Patients' pain is assessed before the first postoperative analgesic with the VAS scale.The rate of healing and swelling is assessed at one, three and seven days after surgery.Dry socket and infection are recorded within a week if present.
Main outcome variables
Pain rate; healing rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171216037893N6
Registration date:2021-12-16, 1400/09/25
Registration timing:registered_while_recruiting
Last update:2021-12-16, 1400/09/25
Update count:0
Registration date
2021-12-16, 1400/09/25
Registrant information
Name
Hamidreza Mahaseni aghdam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 6440
Email address
h_mahaseni@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2022-05-11, 1401/02/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of hydrogen peroxide mouthwash with chlorhexidine on healing and pain after surgical removal of impacted mandibular third molars
Public title
Comparison of the effect of hydrogen peroxide mouthwash with chlorhexidine on healing and pain after mandibular impact wisdom tooth surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a mandibular third molar
degree of surgery difficulty (A,B) (Pell and Gregory)
Being between 18-50 years old
Non smoker
Exclusion criteria:
Having systemic diseases
Medication (antipsychotic, anticoagulants, antibiotics and analgesics)
Need for antibiotic prophylaxis (such as immunosuppressed patients)
Having an infection
Any type of bone pathology
History of radiotherapy
Having painful conditions (having teeth with indication for root canal treatment)
Prohibition of surgery for any reason
Pregnancy or breastfeeding
Allergy to lidocaine or mouthwashes
Alcohol and opioid addiction
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients will be divided into two groups of 31, case and control, by non randomized double blinding method. Patients who visit on even days of the week receive the first intervention and patients who visit on odd days receive the second intervention.
Thus, a third party who does not participate in the study will buy mouthwashes and transfer them to the same shaped bottles with two different lid colors. , Which color is related to which type of mouthwash is announced by the same third party, after reviewing the results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University Dental Branch Tehran - Iran
Street address
No. 9, 9th Neyestan St., Pasdaran Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2021-11-29, 1400/09/08
Ethics committee reference number
IR.IAU.DENTAL.REC.1400.134
Health conditions studied
1
Description of health condition studied
healing and pain after surgical removal of impacted mandibular third molars
ICD-10 code
Z48.814
ICD-10 code description
Encounter for surgical aftercare following surgery on the teeth or oral cavity
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before taking the first analgesic after surgery
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before start the operation, 15 cc of Nanosil® mouthwash will be administered to wash their mouths with it for 1 minute. Patients must wash their mouths two times a day with 15 cc from hydrogen peroxide mouthwash for 30 seconds a week after the surgery.
Category
Treatment - Drugs
2
Description
Control group: Before start the operation, 15 cc of chlorhexidine Najho® 0.2% 250mlmouthwash will be administered to wash their mouths with it for 1 minute. Patients must wash their mouths two times a day with 15 cc from chlorhexidine Najho® 0.2% 250ml mouthwash for 30 seconds a week after the surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Azad University of Medical Sciences, Tehran, Iran
Full name of responsible person
Dr Hamid Reza Mahaseni Aghdam
Street address
No. 9, 9th Neyestan St., Pasdaran Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2564 5703
Fax
Email
h_mahaseni@dentaliau.ac.ir
Web page address
http://www.dentaliau.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Arash Azizi
Street address
No. 9, 9th Neyestan St., Pasdaran Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
hamidmahaseni@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Hamidreza Mahaseni aghdam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neyestan St., Pasdaran Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
Email
h_mahaseni@dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamidreza Mahaseni aghdam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental faculty, 9th neyestan street, pasdaran street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2240 6440
Fax
Email
h_mahaseni@dentaliau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamidreza Mahaseni aghdam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental faculty, 9th neyestan street, pasdaran street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2240 6440
Fax
Email
h_mahaseni@dentaliau.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