Effect of Atorvastatin Gel in Treatment of Peri-Implant Mucositis
Design
A randomized, double blind clinical trial was performed with 2 parallel groups.phase 3 clinical trial on 54 patients.Randomization was done with a table of random numbers.
Settings and conduct
At first, after obtaining written informed consent from eligible patients who meet the study inclusion criteria, referring to a private office after clinical examination including determining the depth of probing and bleeding during probing, if the patients meet the clinical inclusion criteria, they are referred to a radiologist for parallel periapical radiography to determine the level of the marginal bone relative to the crest module of the implant. In the test group, the sites will be treated with mechanical debridement and then with atorvastatin 1.2% gel , and in the control group, will be treated with placebo gel. No antibiotics or anti-inflammatory drugs are prescribed after the treatment. Then the clinical parameters to check the effectiveness of 1.2% Atorvastatin gel, at the beginning (before mechanical debridement), 1 and 3 months after the study will be recorded. A custom-made acrylic stent and a periodontal probe will be used to standardize the measurement of clinical parameters.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1.Age greater than or equal to 18 years
2.Severe peri-implant mucositis or mild peri-implantitis
3.Functioning implant for older and equal to one year
Exclusion criteria
1. Regular use of anti-inflammatory drugs in the last three months
2. Curent and former smokers
3.Pregnancy and breastfeeding
4. Uncontrolled diabetes and immune-compromised systemic diseases
Intervention groups
Intervention group will be treated with mechanical debridement and 1.2% atorvastatin gel and control group will be treated with placebo gel
Main outcome variables
Bleeding on Probing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220510054805N1
Registration date:2022-11-28, 1401/09/07
Registration timing:registered_while_recruiting
Last update:2022-11-28, 1401/09/07
Update count:0
Registration date
2022-11-28, 1401/09/07
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
2022-11-01, 1401/08/10
Expected recruitment end date
2023-03-01, 1401/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Atorvastatin Gel in Non-Surgical Treatment of Peri-Implant Mucositis
Public title
Evaluation of the Effect of Atorvastatin Gel in Non-Surgical Treatment of Peri-Implant Mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age greater than or equal to 18 years
Patients with severe peri-implant mucositis or mild peri-implantitis (presence of Bleeding On Probing ( BOP), probing depth greater than 3 mm, no soft tissue recession with or without minimal crestal bone resorption smaller than or equal to 2 mm in periapical radiography
Functioning implant for older and equal to one year
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
The selection of participants in the study will be done by a simple randomization method, individually and with a random number table tool. In this way, a number is written in front of each person's name from the client list. Then a table is designed based on the sample size of the study and we touch a number of the numbers in the table with our eyes closed. The intervention will be done with a parallel design, where the selection of the desired patient for the intervention or the control will be done randomly with a coin tool. In this way, if it is heads, gel A is used for the patient, and if it is tails, gel B is used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: They will not know whether they are receiving medicine or placebo
Researcher and therapist: In terms of packaging, color, and consistency, medicinal gel and placebo are completely similar, and each bottle is labeled with the letters A and B to distinguish it.
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
Ethics committee of Islamic Azad University of Medical sciences Branch Tabriz
Street address
No. 2 of Islamic Azad University of Tabriz branch.,T-way of Ahar towards Basmenj Complex., Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
1401.198
Health conditions studied
1
Description of health condition studied
Peri-Implant Mucositis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bleeding on Probing
Timepoint
Baseline,1 and 3 months
Method of measurement
Periodontal Probe
Secondary outcomes
1
Description
Probing depth
Timepoint
Baseline,1 and 3 months
Method of measurement
Periodontal Probe
2
Description
Pain On Probing
Timepoint
Baseline,1 and 3 months
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: After initial sampling, mechanical debridement and health education, 1.2% atorvastatin gel (1.2 mg/0.1 ml) will be injected in the desired sites and the clinical parameters of the gums will be re-measured after 1 and 3 months.
Category
Treatment - Drugs
2
Description
Control group : After the initial sampling, mechanical debridement and health education, placebo gel will be injected in the desired sites and the clinical parameters of the gums will be re-measured after 1 and 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental office
Full name of responsible person
Azin Khorramdel
Street address
Third Floor., Rush Building., Mokhaberat Square., Valiasr., Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5173876696
Phone
+98 41 3329 6007
Email
a_khorramdel@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Azin Khorramdel
Street address
Third Floor., Rush Building., Mokhaberat Square., Valiasr., Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5173876696
Phone
+98 41 3329 6007
Email
a_khorramdel@yahoo.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
Katayoun Mogharrab Alile
Position
Dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 69, Golestan Ave., Dr Gharib Blvd., Tabriz Town
City
Tanriz
Province
East Azarbaijan
Postal code
۵۱۷۳۷۸۶۶۹۶
Phone
+98 41 3443 2402
Email
Katayoun.m.98@gmail.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., Mokhaberat Square., Valiasr., Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5173876696
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
Katayoun Mogharrab Alile
Position
Dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 69, Golestan Ave., Dr Garib Blvd., Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۷۳۸۷۶۶۹۶
Phone
+98 41 3443 2402
Email
Katayoun.m.98@gmail.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
Yes - There is 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
Excel software and All data will be shared after de-identification.
When the data will become available and for how long