- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03644901
Assessment of Response to the Conventional Periodontal Treatment Based on the Blood Group Phenotypes.
March 12, 2019 updated by: Damascus University
Investigating the Role of ABO Blood Group in the Response to the Nonsurgical Periodontal Treatment.
The aim of this study is to find out if one blood group phenotype is more responsive than the others to the nonsurgical periodontal treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To the best of our knowledge, this is the first (research) randomized clinical trial that assesses how patient respond to the nonsurgical periodontal treatment based on their blood group phenotype.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Damascus, Syrian Arab Republic, DM20AM18
- Department of Periodontics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients suffering from chronic periodontitis
Description
Inclusion Criteria:
- systematically healthy.
- have at least 20 teeth excluding the third molars.
- had not received any periodontal treatment or antibiotic therapy for dental or medical reason 6 month prior to the study.
- diagnosed with generalized chronic periodontitis (>30% of the sites have probing depth ≥4), and a minimum of six teeth with probing depth of 5-6 mm.
Exclusion Criteria:
- smokers and alcoholics.
- pregnancy.
- history of a systematic disease such as diabetes, leukemia, epilepsy.
- participants who are unable to perform routine oral hygiene.
- use of orthodontic appliances.
- participants who are unable to perform routine oral hygiene.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients whose blood type is A
Applying nonsurgical periodontal treatment (scaling and root planning).
|
patients will undergo nonsurgical periodontal treatment to reduce the relative attachment level and improve the probing depth.
An initial session will be conducted to remove supra gingival plaque and calculus.
another appointment is set to perform full moth scalling and root planing.
Other Names:
|
Patients whose blood type is B
Applying nonsurgical periodontal treatment (scaling and root planning).
|
patients will undergo nonsurgical periodontal treatment to reduce the relative attachment level and improve the probing depth.
An initial session will be conducted to remove supra gingival plaque and calculus.
another appointment is set to perform full moth scalling and root planing.
Other Names:
|
Patients whose blood type is AB
Applying nonsurgical periodontal treatment (scaling and root planning).
|
patients will undergo nonsurgical periodontal treatment to reduce the relative attachment level and improve the probing depth.
An initial session will be conducted to remove supra gingival plaque and calculus.
another appointment is set to perform full moth scalling and root planing.
Other Names:
|
Patients whose blood type is O
Applying nonsurgical periodontal treatment (scaling and root planning).
|
patients will undergo nonsurgical periodontal treatment to reduce the relative attachment level and improve the probing depth.
An initial session will be conducted to remove supra gingival plaque and calculus.
another appointment is set to perform full moth scalling and root planing.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in relative attachment level.
Time Frame: measures will be taken at baseline and after two months from treatment.
|
the relative attachment level measures the length form the base of the periodontal pocket to a stent
|
measures will be taken at baseline and after two months from treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in periodontal probing depth.
Time Frame: measures will be taken at baseline and after two months from treatment.
|
the distance between the gingival margin to the base of the periodontal pocket.
|
measures will be taken at baseline and after two months from treatment.
|
Change in gingival index
Time Frame: index will be taken at baseline and after two months from treatment.
|
it is used to designate the level of the gingival inflammation.
|
index will be taken at baseline and after two months from treatment.
|
Change in plaque Index
Time Frame: index will be taken at baseline and after two months from treatment.
|
it is used to designate the level of plaque accumulation.
|
index will be taken at baseline and after two months from treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohammad Ammar Kouky, DDS MSc, PhD Student in Periododontics, University of Damascus Dental School, Damascus
- Study Chair: Mohammad Monzer Alsabbagh, DDS MSc PhD, Associate Professor of Periodontics, University of Damascus Dental School, Damascus, Syria
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pai GP, Dayakar MM, Shaila M, Dayakar A. Correlation between "ABO" blood group phenotypes and periodontal disease: Prevalence in south Kanara district, Karnataka state, India. J Indian Soc Periodontol. 2012 Oct;16(4):519-23. doi: 10.4103/0972-124X.106892.
- Demir T, Tezel A, Orbak R, Eltas A, Kara C, Kavrut F. The Effect of ABO Blood Types on Periodontal Status. Eur J Dent. 2007 Jul;1(3):139-43.
- Gautam A, Mittal N, Singh TB, Srivastava R, Verma PK. Correlation of ABO Blood Group Phenotype and Rhesus Factor with Periodontal Disease: An Observational Study. Contemp Clin Dent. 2017 Apr-Jun;8(2):253-258. doi: 10.4103/ccd.ccd_307_17.
- Wang W, Liu L, Wang Z, Wei M, He Q, Ling T, Cao Z, Zhang Y, Wang Q, Shi M. Impact of ABO blood group on the prognosis of patients undergoing surgery for esophageal cancer. BMC Surg. 2015 Sep 29;15:106. doi: 10.1186/s12893-015-0094-1.
- Yu Q, Wang L, Zhang S, Feng T, Li L, Chen B, Chen M. The role of ABO blood groups in Crohn's disease and in monitoring response to infliximab treatment. Blood Transfus. 2016 Sep;14(5):460-4. doi: 10.2450/2016.0199-15. Epub 2016 Feb 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 15, 2018
Primary Completion (ACTUAL)
October 1, 2018
Study Completion (ACTUAL)
March 10, 2019
Study Registration Dates
First Submitted
August 2, 2018
First Submitted That Met QC Criteria
August 22, 2018
First Posted (ACTUAL)
August 23, 2018
Study Record Updates
Last Update Posted (ACTUAL)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 12, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UDDS-Perio-03-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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