MedDataX Logo

The Impact of Obesity on Nonsurgical Periodontal Therapy

NCT ID: NCT01405365

Last Updated: 2011-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate the effect that obesity may have on the nonsurgical treatment (with and without the adjunct use of metronidazole) of destructive periodontal diseases (chronic periodontitis).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Normal weight (BMI 18.5-24.9 kg/m2) and obese (BMI \>30 kg/m2) women will be randomly assigned to two nonsurgical periodontal treatments:

1. scaling and root planing + placebo
2. scaling and root planing + metronidazole

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periodontitis Periodontal Diseases Obesity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Periodontitis Periodontal diseases Obesity Metronidazole Prognosis Probing depth Periodontal attachment loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metronidazole

Group Type EXPERIMENTAL

Metronidazole

Intervention Type DRUG

Metronidazole 400mg TID for 10 days

Scaling and root planning

Intervention Type PROCEDURE

Scaling and root planning performed with curettes and ultrasonic scalers under local anesthesia

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo pill TID for 10 days

Scaling and root planning

Intervention Type PROCEDURE

Scaling and root planning performed with curettes and ultrasonic scalers under local anesthesia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metronidazole

Metronidazole 400mg TID for 10 days

Intervention Type DRUG

Placebo

Placebo pill TID for 10 days

Intervention Type DRUG

Scaling and root planning

Scaling and root planning performed with curettes and ultrasonic scalers under local anesthesia

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Flagyl Inactive Substance Inactive Drug Nonsurgical periodontal therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Normal weight or obese (according to BMI)
* nonsmokers or former smokers (3 or more years)
* no systemic diseases that may affect periodontal treatment (diabetes, osteoporosis, steroid use)
* have 10 teeth present
* have at least 2 teeth with probing depth 6+mm and attachment loss 4+mm

Exclusion Criteria

* Pregnancy
* Development of diabetes or other conditions that may impair periodontal healing
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Augusta University

OTHER

Sponsor Role collaborator

Federal University of Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Faculdade de Odontologia, Universidade Federal do Rio Grande do Sul

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cassiano K Rosing, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Cristiano Susin, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Georgia School of Dentistry

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Eduardo J Gaio, DDS

Role: CONTACT

Phone: 55 51 9252 4577

Email: [email protected]

Juliano Cavagni, DDS

Role: CONTACT

Phone: 55 54 8111 9440

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Eduardo J Gaio, DDS

Role: primary

Juliano Cavagni, DDS

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CNPq-402335/2008-2

Identifier Type: -

Identifier Source: org_study_id