Comparative evaluation of locally delivered 1.2% Rosuvastatin gel, 1% Metformin gel and placebo as an adjunct to scaling and root planing in the treatment of moderate to severe chronic periodontitis patients
The aim of the present study is to evaluate and compare the clinical efficacy of locally delivered 1.2% Rosuvastatin and 1% Metformin gel as an adjunct to scaling and root planing in the treatment of moderate to severe chronic periodontitis patients.
Design
Clinical trial with control group, parallel group design of 30 patients, single blinded, phase 2.
Settings and conduct
In the periodontology department of Ahvaz University of Medical Sciences, 30 patients with moderate to severe chronic periodontitis were selected by available sampling method and were randomly divided into 3 treatment groups during the process: 1)SRP plus 1.2% RSV gel 2)SRP plus 1% MF gel 3)SRP plus placebo gel. Clinical parameters including Pocket Probing Depth, Clinical Attachment Level, Modified Sulcus Bleeding Index and Plaque Index were recorded at baseline before SRP and after 3 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Moderate to severe chronic periodontitis patients with no history of any kind of periodontal or antibiotic therapy in the last 6 month. Exclusion criteria: Patients with any disabling systemic disease or a systemic disease that affects the periodontium, systemic statin or metformin therapy, Diabetic patients, known or suspected allergy to statins or metformin, Immunocompromised patients, Pregnant or lactating women, Individuals who use any forms of tobacco and alcoholics.
Intervention groups
1)Scaling and root planing plus 1.2% Resuvastatin gel 2)Scaling and root planing plus 1% Metformin gel 3)Scaling and root planing plus placebo gel.
Main outcome variables
Pocket Probing Depth ; Clinical Attachment Level ; Modified Sulcus Bleeding Index ; Plaque Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191024045232N1
Registration date:2020-11-04, 1399/08/14
Registration timing:retrospective
Last update:2020-11-04, 1399/08/14
Update count:0
Registration date
2020-11-04, 1399/08/14
Registrant information
Name
Saminalsadat Ayoubi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 2491
Email address
ayoubi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
2019-10-01, 1398/07/09
Actual recruitment end date
2019-12-14, 1398/09/23
Trial completion date
2020-04-08, 1399/01/20
Scientific title
Comparative evaluation of locally delivered 1.2% Rosuvastatin gel, 1% Metformin gel and placebo as an adjunct to scaling and root planing in the treatment of moderate to severe chronic periodontitis patients
Public title
Comparative evaluation of locally delivered 1.2% Rosuvastatin gel, 1% Metformin gel and placebo as an adjunct to scaling and root planing in the treatment of moderate to severe chronic periodontitis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to severe chronic periodontitis patients with probing depth≥5mm and clinical attachment loss≥3mm.
Patients with no history of any kind of periodontal or antibiotic therapy in the last 6 months.
Exclusion criteria:
Individuals with any disabling systemic disease or a systemic disease that affects the periodontium.
Patients on systemic statin or metformin therapy.
Diabetic patients
Patients with known or suspected allergy to statins or metformin.
Immunocompromised patients.
Pregnant or lactating women.
Individuals who use any forms of tobacco and alcoholics.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single blind study, participants did not know which of the two control or experimental groups they belonged to. But the principle investigator knew who was in what group.
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 Scineces
Street address
No. 112,West 13th st.,Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155863861
Approval date
2019-09-21, 1398/06/30
Ethics committee reference number
IR.AJUMS.REC.1398.449
Health conditions studied
1
Description of health condition studied
Periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Pocket Probing Depth
Timepoint
Before scaling and root planing (baseline) and after 3 months
Method of measurement
UNC 15 color-coded periodontal probe
2
Description
Clinical Attachment Level
Timepoint
Before scaling and root planing (baseline) and after 3 months
Method of measurement
UNC 15 color-coded periodontal probe
3
Description
Modified Sulcus Bleeding Index
Timepoint
Before scaling and root planing (baseline) and after 3 months
Method of measurement
Scoring system of Mombelli
4
Description
Plaque Index
Timepoint
Before scaling and root planing (baseline) and after 3 months
Method of measurement
Scoring system of Silness and Loe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first intervention group, treatment has been done by scaling and root planing with only single injection of 0.1ml Resuvastatin gel [consisting of 1.2% Resuvastatin (high purity that has been provided by Abidi Pharmaceutical Company), 4% hydroxypropyl methylcellulose, 5% glycerin And up to 100% water], immediately after scaling the whole mouth using a syringe with blunt tip into the pocket that has the highest probing depth and clinical attachment loss with BoP (one area per patient). In the second intervention group, treatment has been done by scaling and root planing with only single injection of 0.1ml Metformin gel [consisting of 1% Metformin (high purity that has been provided by Abidi Pharmaceutical Company), 4% hydroxypropyl methylcellulose, 5% glycerin and up to 100% water], immediately after scaling the whole mouth using a syringe with blunt tip into the pocket that has the highest probing depth and clinical attachment loss with BoP (one area per patient). Patients in both groups are given the same oral hygiene instruction and are advised not to chew any hard or sticky foods and not to brush near the treated site or to use any interdental aids for a duration of one week. No anti-inflammatory or anti-plaque mouthwash and no antibiotics are prescribed after treatment. In the recall visits, any adverse effects are recorded and any supragingival plaque or calculus is removed.
Category
Treatment - Drugs
2
Description
Control group: In the control group, treatment has been done by scaling and root planing with only single injection of 0.1ml placebo gel, immediately after scaling the whole mouth using a syringe with blunt tip into the pocket that has the highest probing depth and clinical attachment loss with BoP (one area per patient). Patients are given oral hygiene instruction similar to the intervention groups and are advised not to chew any hard or sticky foods and not to brush near the treated site or to use any interdental aids for a duration of one week. No anti-inflammatory or anti-plaque mouthwash and no antibiotics are prescribed after treatment. In the recall visits, any adverse effects are recorded and any supragingival plaque or calculus is removed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of periodontics, Faculty of dentistry, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Saminalsadat Ayoubi
Street address
No. 112,West 13th st.,Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155863861
Phone
+98 61 3338 2491
Email
Ayoubi.samin@gmail.com
Web page address
http://behsan.ajums.ac.ir/general/homePage.action
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
No. 112,West 13th st.,Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155863861
Phone
+98 61 3338 2491
Email
ayoubi.samin@gmail.com
Web page address
http://behsan.ajums.ac.ir/general/homePage.action
Grant name
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
Saminalsadat Ayoubi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 112,West 13th st.,Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155863861
Phone
+98 61 3338 2491
Email
Ayoubi.samin@gmail.com
Web page address
http://behsan.ajums.ac.ir/general/homePage.action
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Azarnoosh Aryankia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of periodontics, Faculty of dentistry, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
0098 61 3311
Email
aryankiaa@gmail.com
Web page address
http://behsan.ajums.ac.ir/general/homePage.action
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Saminalsadat Ayoubi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 112,West 13th st.,Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155863861
Phone
+98 61 3338 2491
Email
Ayoubi.samin@gmail.com
Web page address
http://behsan.ajums.ac.ir/general/homePage.action
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