NCT04262999

Brief Summary

Assessment of bone mineral density and periodontal parameters in patients with epilepsy. Comparative evaluation of bone mineral density and levels of marginal alveolar bone in patients with epilepsy on monotherapy, combination therapy, and systemically healthy individuals.Comparative evaluation of periodontal parameters in all the patients who are on monotherapy and combination therapy and in systemically healthy individuals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

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 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

February 6, 2020

Last Update Submit

February 6, 2020

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (2)

  • Bone mineral density

    DUAL ENERGY X-RAY ABSORPTIOMETRY (DEXA)- There are two s.d. scores, T-scores and Z-scores. The T-scores compare the BMD values obtained with a sex-matched and race matched population at peak BMD, while the Z-scores compare the BMD measurements with an age-matched population. According to the WHO, patients with scores that are 1 - 2.5 s.d. below normal DEXA-values have osteopenia, while those with values \>2.5 s.d. below normal values are described as osteoporotic. When evaluating DEXA scans, 1 s.d. represents a T-score of 1. Thus, a patient with an s.d. of 3 below normal (i.e., osteoporosis) will have a T-score of -3.

    1year

  • Marginal alveolar bone levels

    By using RVG with the help of XCP-film holder, levels of marginal bone will be measured from Cemento-enamel junction to crest of alveolar bone on mesial and distal aspect of index teeth (first molar of each quadrant and central and lateral incisors of 2nd and 4th quadrant) Index teeth for scoring will be 1st molar from each quadrant and central and lateral incisor of 2nd and 4th quadrant. If index teeth are missing then we will take adjacent teeth as index teeth in our study.

    1 year

Secondary Outcomes (5)

  • Plaque Index (PI)

    1year

  • Gingival Index (GI)

    1year

  • Bleeding On Probing (BOP)

    1year

  • Pocket Probing Depth (PPD)

    1year

  • Clinical Attachment Loss (CAL)

    1year

Study Arms (4)

drug sodium valproate

individuals on antiepileptic drug sodium valproate for at least 1 year at the time of participation of the study.

Other: effect of sodium valproate on alveolar bone level

drug levetiracetam

individuals on antiepileptic drug levetiracetam monotherapy for at least 1 year at the time of participation of the study.

Other: effect of levetiracetam on alveolar bone level

drug sodium valproate + levetiracetam

individuals on antiepileptic drug sodium valproate + levetiracetam combination therapy for at least 1 year at the time of participation of the study.

Other: effect of sodium valproate+levetiracetam on alveolar bone level

control group

systemically healthy individuals

Other: control group

Interventions

effect of sodium valproate on alveolar bone levelOTHER

Comparative evaluation of bone mineral density and levels of marginal alveolar bone in patients with epilepsy on sodium valproate drug therapy.Comparative evaluation of periodontal parameters in all the patients who are on sodium valproate drug therapy.

drug sodium valproate
effect of levetiracetam on alveolar bone levelOTHER

Comparative evaluation of bone mineral density and levels of marginal alveolar bone in patients with epilepsy on levetiracetam drug therapy.Comparative evaluation of periodontal parameters in all the patients who are on levetiracetam drug therapy.

drug levetiracetam
effect of sodium valproate+levetiracetam on alveolar bone levelOTHER

Comparative evaluation of bone mineral density and levels of marginal alveolar bone in patients with epilepsy on sodium valproate+levetiracetam drug therapy.Comparative evaluation of periodontal parameters in all the patients who are on sodium valproate+ levetiracetam drug therapy.

drug sodium valproate + levetiracetam
control groupOTHER

Control group individuals will be systemically healthy.

control group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients in the test group will be recruited from the Outpatient Department of Neurology, Post Graduate Institute of Medical Sciences, Rohtak. Patients in the control group will be recruited from the Department of Oral Medicine and Radiology, Post Graduate Institute of Dental Sciences, Rohtak.

You may qualify if:

  • Individuals will be included in the study with the age range of 18-40 years. The selection of individuals will be according to age group, body mass index, and duration of drug therapy.
  • Control group individuals will be systemically healthy. Test group individuals will comprise of individuals diagnosed with epilepsy according to the International League Against Epilepsy (ILAE) criteria,1981 and monitored by the Department of Neurology, Post Graduate Institute of Medical Sciences, Rohtak.
  • The duration of antiepileptic drugs should at least 1 year at the time of enrollment.

You may not qualify if:

  • Individuals who are already taking steroid therapy, Bisphosphonates therapy. Individuals on vitamins and calcium supplements. With a history of substance abuse (Tobacco/Alcohol) Malabsorption syndrome (Ulcerative colitis, Crohn's disease, Celiac disease, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Swati Jaglan, MDS

    Post Graduate Institute of Dental Sciences,Rohtak

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Satish C Narula, MDS

CONTACT

01262283876scnarula@gmail.com

Satish C Narula, MDS

CONTACT

01262283876

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 10, 2020

Study Start

January 1, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

February 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Study protocol

Shared Documents
STUDY PROTOCOL

Locations

IN(1)