Chronic PeriodontitisNCT03644901
Assessment of Response to the Conventional Periodontal Treatment Based on the Blood Group Phenotypes.
An observational study of Chronic Periodontitis, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- nonsurgical periodontal treatment
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSyria
- Study dates
- 15 Jan 2018to 10 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients suffering from chronic periodontitis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Periodontitis
- Being tested
- nonsurgical periodontal treatment
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonsurgical periodontal treatmentProcedure or surgery
Also called Conventional periodontal treatment, scalling and root planing
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients whose blood type is A | Applying nonsurgical periodontal treatment (scaling and root planning). Receives: Procedure: nonsurgical periodontal treatment | |
| Patients whose blood type is B | Applying nonsurgical periodontal treatment (scaling and root planning). Receives: Procedure: nonsurgical periodontal treatment | |
| Patients whose blood type is AB | Applying nonsurgical periodontal treatment (scaling and root planning). Receives: Procedure: nonsurgical periodontal treatment | |
| Patients whose blood type is O | Applying nonsurgical periodontal treatment (scaling and root planning). Receives: Procedure: nonsurgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in relative attachment level.
the relative attachment level measures the length form the base of the periodontal pocket to a stent
Measured: measures will be taken at baseline and after two months from treatment.
Secondary outcomes (3)
Change in periodontal probing depth.
the distance between the gingival margin to the base of the periodontal pocket.
Measured: measures will be taken at baseline and after two months from treatment.
Change in gingival index
it is used to designate the level of the gingival inflammation.
Measured: index will be taken at baseline and after two months from treatment.
Change in plaque Index
it is used to designate the level of plaque accumulation.
Measured: index will be taken at baseline and after two months from treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start15 Jan 2018
- Primary completion1 Oct 2018
- Study completion10 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Ammar Kouky, DDS MSc, Principal investigator, PhD Student in Periododontics, University of Damascus Dental School, DamascusMohammad Monzer Alsabbagh, DDS MSc PhD, Study chair, Associate Professor of Periodontics, University of Damascus Dental School, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644901
- Sponsor's protocol ID
- UDDS-Perio-03-2018
- Status last verified
- Mar 2019
- First submitted
- 2 Aug 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23493096Demir 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.
PubMed 19212557Gautam 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.
PubMed 28839412Wang 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.
PubMed 26420728Yu 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.
PubMed 27136434
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of ABO Blood Group in the Response to the Nonsurgical Periodontal Treatment.
- ClinicalTrials.gov ID
- NCT03644901
- Acronym / sponsor ID
- UDDS-Perio-03-2018
- Conditions
- Chronic Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 10 Mar 2019 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients whose blood type is A | – | Procedure: nonsurgical periodontal treatmentApplying nonsurgical periodontal treatment (scaling and root planning). |
| Patients whose blood type is B | – | Procedure: nonsurgical periodontal treatmentApplying nonsurgical periodontal treatment (scaling and root planning). |
| Patients whose blood type is AB | – | Procedure: nonsurgical periodontal treatmentApplying nonsurgical periodontal treatment (scaling and root planning). |
| Patients whose blood type is O | – | Procedure: nonsurgical periodontal treatmentApplying nonsurgical periodontal treatment (scaling and root planning). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients suffering from chronic periodontitis
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nonsurgical periodontal treatmentAlso: Conventional periodontal treatment, scalling and root planingpatients 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. | Procedure or surgery | Patients whose blood type is A, Patients whose blood type is AB, Patients whose blood type is B, Patients whose blood type is O |
Primary outcome
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
3 secondary outcomes
Change in periodontal probing depth.
Time frame: 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.
Change in plaque Index
Time frame: index will be taken at baseline and after two months from treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Background: PubMed 23493096Pai 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.
- Background: PubMed 19212557Demir 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.
- Background: PubMed 28839412Gautam 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.
- Background: PubMed 26420728Wang 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.
- Background: PubMed 27136434Yu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Ammar Kouky, DDS MSc principal investigator
PhD Student in Periododontics, University of Damascus Dental School, Damascus
Mohammad Monzer Alsabbagh, DDS MSc PhD study chair
Associate Professor of Periodontics, University of Damascus Dental School, Damascus, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Periodontitis, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in relative attachment level. (time frame: measures will be taken at baseline and after two months from treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644901, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.