Effects of local and systemic Metronidazole as adjunctive treatment in patients suffering from chronic periodontitis
Design
Phase 3, single-blinded, two arm parallel group randomized trial on 30 patients.
Settings and conduct
30 patients with inclusion criteria who have referred to Alborz Dental Clinic in Urmia or dental office will be randomly divided into three groups. For the the treatment of patients in the first group only Scaling and Root Planing (SRP), in the second group the usual SRP and side treatment in the form of metronidazole tablets in which 20 metronidazole 250 mg tablets every eight hours for a week after mechanical debridement will be prescribed. In the group Third, the usual SRP and side treatment will be prescribed as metronidazole gel. After receiving the standard SRP, 0.75% metronidazole gel will be placed by a non-cutting end syringe inside the 3 pockets included in the study, until the pocket is completely filled. Pocket Probing Depth , Clinical Attachment Level and Bleeding On Probing are assessed at the beginning of the study and 3 months later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients diagnosed with chronic periodontitis with at least three non-adjacent pockets with a probing depth equal to or greater than 4 mm with general health who have not taken any anti-inflammatory drugs or antibiotics in the past six months. Exclusion criteria: To have any allergies to metronidazole or O'Leary plaque index more than 15% after proper oral hygiene training.
Intervention groups
1) The usual treatment of Scaling and root planing (SRP) and side treatment in the form of metronidazole tablets.
2) The usual treatment of Scaling and root planing (SRP) and side treatment in the form of metronidazole gel.
Effects of local and systemic Metronidazole as adjunctive treatment in patients suffering from chronic periodontitis
Public title
ٍEffects of Metronidazole gel and tablets in gingival disease treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient diagnosed with chronic periodontitis with at least three non-adjacent pockets with probing depth equal to or greater than 4 mm.
Patients with systemic health.
Patients who have not taken any anti-inflammatory drugs or antibiotics in the last six months.
Patients with at least 15 teeth (except third molars) in their mouth.
Patients with proper cooperation.
Patients who have signed an informed written consent form.
Exclusion criteria:
Patients with medical problems who need antibiotic prophylaxis or treatment intervention.
Patients who have had periodontal treatment in the last six months.
Patients who have used drugs that affect their periodontal status (such as antibiotics, anti-inflammatory drugs, anticonvulsants, immunosuppressive drugs, and calcium channel blockers) in the last six months.
Patients who have undergone orthodontic treatment.
Pregnant and lactating patients.
Patients with systemic diseases such as diabetes and immunological disorders.
O’Leary plaque index more than 15% after proper oral hygiene training.
History of Metronidazole allergy.
Age
From 30 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
3
خالی
Randomization (investigator's opinion)
Randomized
Randomization description
Patients included in the study will be divided into a control group and two intervention groups based on the pre-generated randomization sequence, which is random and unpredictable. To divide the samples, the block randomization method with the blocks size of 3 and 6 will be used; In this way, by block random number generation software, a random sequence will be generated according to the required sample size for the three groups. First, all the cases in which the three letters A, B, and C can be put together in blocks of 3 and 6 are generated and randomly selected by placing a block between the blocks, and from the layout pattern of that block to patient classification will be used; Then this block will be placed in the main container and we will select another block again. All the blocks of 3 and 6 will be placed in one container.
Sealed Envelope software will be used to perform this process.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person reviewing the results of the use of different forms of medication in the participants, as well as the person analyzing the data, do not know the treatment method and the form of medication used in each participant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Ethics committee of Urmia University of Medical Sciences, Urgans Ave, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2020-12-23, 1399/10/03
Ethics committee reference number
IR.UMSU.REC.1399.319
Health conditions studied
1
Description of health condition studied
Chronic Periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Pocket Probing Depth
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Periodontal Probe
2
Description
Clinical Attachment Level
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Periodontal Probe
3
Description
Bleeding On Probing
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Visual
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Receiving of Scaling and Root Planing by ultrasonic cavitron
Category
Treatment - Devices
2
Description
First intervention group: In this group, after Scaling and Root Planing by ultrasonic cavitron ,twenty 250 mg tablets Metronidazole tablets made by Tehran Shimi Company are prescribed every eight hours for a week.
Category
Treatment - Drugs
3
Description
Second intervention group: In this group, after Scaling and Root Planing by ultrasonic cavitron , 0.75% Metronidazole gel made by Pars Daroo Company is placed inside the pockets included in the study until the pocket is completely filled by a syringe with a non-cutting end needle. The gel is reused one week, two weeks and three weeks later.