NCT05676736

Brief Summary

Periodontal disease is defined as "an inflammatory disease of the tooth supportive structure caused by specific microorganisms or groups of specific microorganisms, resulting in progressive destruction of the periodontal ligament and alveolar bone with increased probing depth formation, recession, or both". According to WHO, overweight and obesity are defined as abnormal or excessive fat accumulation that may impair health. Body mass index (BMI) can be considered as an indicator of obesity-related health risks. Obesity was considered a global epidemic problem by the World Health Organization in the 1990s as it has increased internationally over the last decades. Based on review in 2003 the periodontal disease onset, progression and response to therapeutic interventions have been shown to be influenced by several systemic, local and environmental modifying factors and the data collected from the literature suggests that nutritional supplementation has been suggested as a possible influencing factor on periodontal status and wound healing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
384

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

December 31, 2022

Last Update Submit

September 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • - The primary outcome of the study is the periodontal health in association with obesity

    The periodontal health status evaluated by full mouth charting using UNC 15 peiodontal probe, including probing depth (PD), clinical attachment Level (CAL), bleeding on probing (BOP), plaque index (PI).

    Day 1

Study Arms (2)

Study group (S) Obese group

Patients with body mass index (BMI) range from (≥30 kg/m2)

Other: No intervention

Control group (C) Normal weight group

Patients with body mass index (BMI) range from (18.5-24.9 kg/m2)

Other: No intervention

Interventions

No intervention to be done for the group

Control group (C) Normal weight groupStudy group (S) Obese group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

\- Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.

You may qualify if:

  • Patients whose age is between 18-60 years old.
  • Provide informed consent.
  • Patient have at least 20 natural teeth.
  • Patient had no received periodontal treatment within previous 4 months.

You may not qualify if:

  • Individuals with chronic systemic diseases such as cancer, osteoporosis, endocrine and hematological Pathologies.
  • Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.
  • Pregnant women.
  • Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
  • Patients with orthodontic appliances.
  • Patient had autoimmune condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 115, Egypt

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mai Zakaria, ph

    Associate professor Oral Medicine & Periodontology, Faculty of Dentistry, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor Oral Medicine & Periodontology

Study Record Dates

First Submitted

December 31, 2022

First Posted

January 9, 2023

Study Start

December 1, 2022

Primary Completion

April 20, 2023

Study Completion

May 30, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

individual participant data are not to be shared with other researchers until publication of the study.

Locations