The comparison of the effect of metronidazole gel as an adjuant to mechanical debridementand mechanical debridement alone in peri-implantitis treatment
Determining the effect of metronidazole gel as a complement to mechanical debridement with mechanical debridement alone in the treatment of peri-implantitis.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, on 32 patients who used a table of random numbers for randomization.
Settings and conduct
at first, after obtaining a written informed consent form from the qualified patients referring to the private practice, after a clinical examination including determining the probing depth and bleeding during probing, if the patient meets the clinical entry criteria, he is referred to a radiologist for a parallel periapical radiograph for Determination of the marginal bone level relative to the implant module crest. In the test group, the sites will be treated with mechanical debridement and then metronidazole gel, and the control group will be treated with mechanical debridement and placebo. No anti-inflammatory or antibiotic drugs should be used after the treatment.Then clinical parameters will be recorded to check the effectiveness of metronidazole gel at the beginning (before mechanical debridement),1and3 months after the treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
- Presence of peri-implantitis disease
- No history of peri-implantitis surgical treatment
- Patient 18 years and older
- Positive BOP
- Bone resorption rate > 2mm
- Not using antibiotics, mouthwash and periodontal treatment in the last 6 weeks
Exit criteria:
- Pregnancy
- Breastfeeding
- Use of anticoagulants
- underlying disease (diabetes, kidney disorders, etc.)
- smoking
Intervention groups
In the intervention group, the sites will be treated with mechanical debridement and then metronidazole gel. And in the control group, the sites will be treated with mechanical debridement and then placebo.
Main outcome variables
bleeding on probing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220510054805N2
Registration date:2022-12-30, 1401/10/09
Registration timing:prospective
Last update:2022-12-30, 1401/10/09
Update count:0
Registration date
2022-12-30, 1401/10/09
Registrant information
Name
Azin Khorramdel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3384 0468
Email address
dr.khorramdel@iaut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-31, 1401/10/10
Expected recruitment end date
2023-03-18, 1401/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of metronidazole gel as an adjuant to mechanical debridementand mechanical debridement alone in peri-implantitis treatment
Public title
The comparison of the effect of metronidazole gel as an adjuant to mechanical debridementand mechanical debridement alone in peri-implantitis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age greater than or equal to 20 years
بیمار مبتلا به پری ایمپلنتایتیس
The selection of participants in the study will be done by a simple random method, individually and with a random number table tool. In this way, a number is written in front of the name of each person from the client list, and then a table will be prepared based on the sample size. The selected numbers will be included in the study if they are eligible after the examination. The study will be conducted with a parallel design in which the selection of the desired patient for intervention or control is done randomly with a coin tool. For the patient if it is head, mechanical debridement will be performed along with metronidazole gel, and if is tails, mechanical debridement will be performed alone.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: will not know whether they are receiving drug or placebo.
Researcher and therapist: In terms of packaging, color and consistency, medicinal gel and placebo are completely similar and are named only with letters A and B.
Data analyzer: The data is evaluated numerically without specifying the side with gel and placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethics commitees of islamic azad university-tabriz branch
Street address
Complex No. 2 of Islamic Azad University, Tabriz branch, To Basmenj, Ahr Tee, Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
5157944533
Approval date
2022-12-13, 1401/09/22
Ethics committee reference number
IR.IAU.TABRIZ.REC.1401.261
Health conditions studied
1
Description of health condition studied
peri-implantitis
ICD-10 code
M27.69
ICD-10 code description
Other endosseous dental implant failure
Primary outcomes
1
Description
Bleeding during probing
Timepoint
Before starting the intervention and 1 and 3 months after the treatment
Method of measurement
up to 30 seconds after probing, the probed areas are evaluated and in case of visible bleeding, it is recorded in the patient's chart and reported as a percentage for each implant.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after the initial sampling, mechanical debridement and health education, metronidazole gel in the intended injection sites and the clinical parameters of the gums are measured again after 1 and 3 months.
Category
Treatment - Drugs
2
Description
Control group: After the initial sampling, mechanical debridement and health education, placebo in the injection sites and the clinical parameters of the gums are measured again after 1 and 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Third floor, Rush building, It has not reached the telecommunication area, Waliasr
Full name of responsible person
Arash Ghorbanzadeh
Street address
Third floor, Rush building, It has not reached the telecommunication area, Waliasr
City
Tabriz
Province
East Azarbaijan
Postal code
5155673547
Phone
+98 41 3329 6007
Email
arash7070@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Reza Shaham Far - Assistant Researcher
Street address
Complex No. 2 of Islamic Azad University, Tabriz branch
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3637 7707
Email
info@iaut.ac.ir
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
1
Public or private sector
Private
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
Azin Khorramdel
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Complex No. 2 of Islamic Azad University, Tabriz branch
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3637 7707
Email
A_khorramdel@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Azin Khorramdel
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Third floor, Rush building, Waliasr
City
Tabriz
Province
East Azarbaijan
Postal code
5155673547
Phone
+98 41 3329 6007
Email
A_khorramdel@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Azin Khorramdel
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Rush bulding,waliasr
City
Tabriz
Province
East Azarbaijan
Postal code
5155673547
Phone
+98 41 3329 6007
Email
A_khorramdel@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
all
When the data will become available and for how long
1402
To whom data/document is available
all
Under which criteria data/document could be used
Research
From where data/document is obtainable
dr khorramdel
What processes are involved for a request to access data/document