Clinical trial NCT03644901: Assessment of Response to the Conventional Periodontal Treatment Based on the Blood Group Phenotypes.
Official title: Investigating the Role of ABO Blood Group in the Response to the Nonsurgical Periodontal Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Periodontitis
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from chronic periodontitis

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in relative attachment level.
timeFrame: measures will be taken at baseline and after two months from treatment.
Secondary outcomes:
measure: Change in periodontal probing depth.
timeFrame: measures will be taken at baseline and after two months from treatment.
measure: Change in gingival index
timeFrame: index will be taken at baseline and after two months from treatment.
measure: Change in plaque Index
timeFrame: index will be taken at baseline and after two months from treatment.
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Periodontics
Study officials:
affiliation: PhD Student in Periododontics, University of Damascus Dental School, Damascus
name: Mohammad Ammar Kouky, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Periodontics, University of Damascus Dental School, Damascus, Syria
name: Mohammad Monzer Alsabbagh, DDS MSc PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.