NCT03311243

Brief Summary

The study aims to evaluate the effect of local non surgical periodontal therapy on the systemic pro-inflammatory markers in the β-thalassemia (TM-β) patients with chronic periodontitis and systemically healthy demographically matched controls with chronic periodontitis. Both groups will receive non surgical periodontal therapy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

October 11, 2017

Last Update Submit

October 16, 2017

Conditions

Thalassemia MajorChronic Periodontitis

Keywords

cytokinesscaling root planingoral hygienesystemic inflammation

Outcome Measures

Primary Outcomes (1)

  • Systemic pro-inflammatory cytokines

    IL-6 and TNF-alpha potent proinflammatory cytokines

    6 weeks

Study Arms (2)

β-Thalassemia major (TM- β)

EXPERIMENTAL
Procedure: Non surgical periodontal therapyDrug: Chemical plaque control

Systemically healthy controls

ACTIVE COMPARATOR
Procedure: Non surgical periodontal therapyDrug: Chemical plaque control

Interventions

Non surgical periodontal therapyPROCEDURE
Systemically healthy controlsβ-Thalassemia major (TM- β)
Chemical plaque controlDRUG
Systemically healthy controlsβ-Thalassemia major (TM- β)

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Written and verbal consent
  • (TM-β) patients with gingivitis
  • Age: ≥10 years
  • Patients who have received or are receiving iron chelation therapy with deferasirox, calcium, vitamin D, and regular erythrocyte transfusion.

You may not qualify if:

  • Presence of hepatitis B or C or HIV-AIDS (Human immunodeficiency Virus- Acquired immunodeficiency syndrome).
  • Presence of any other known systemic disease.
  • Use of antibiotics or anti-inflammatory drugs within the past 6 months.
  • Dental prophylaxes in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

beta-ThalassemiaChronic Periodontitis

Condition Hierarchy (Ancestors)

ThalassemiaAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 11, 2017

First Posted

October 17, 2017

Study Start

January 11, 2016

Primary Completion

April 10, 2017

Study Completion

June 16, 2017

Last Updated

October 18, 2017

Record last verified: 2017-10