PeriodontitisNCT01405365
The Impact of Obesity on Nonsurgical Periodontal Therapy
A study testing Metronidazole and Scaling and root planning in people with Periodontitis and Periodontal Diseases, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Diseases, Obesity
- What is being tested?
- Metronidazole and Scaling and root planning
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2009to Dec 2012
- Phase
- Interventional
- 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 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Development of diabetes or other conditions that may impair periodontal healing
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90035-003
Eduardo J Gaio, DDS, 55 51 9252 4577
Juliano Cavagni, DDS, 55 54 8111 9440, jcavagni@hotmail.com
About this study
Official title: The Impact of Obesity on Nonsurgical Periodontal Treatment of Destructive Periodontal Diseases
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).
Read the detailed description
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:
- scaling and root planing + placebo
- scaling and root planing + metronidazole
- Conditions
- Periodontitis, Periodontal Diseases, Obesity
- Being tested
- Metronidazole, Placebo, Scaling and root planning
- Keywords
- Periodontitis, Periodontal diseases, Obesity, Metronidazole, Prognosis, Probing depth, Periodontal attachment loss
- Medical subject headings
- Periodontitis, Periodontal Diseases, Obesity, Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Also called Flagyl
Metronidazole 400mg TID for 10 days
PlaceboDrug
Also called Inactive Substance, Inactive Drug
Placebo pill TID for 10 days
Scaling and root planningProcedure or surgery
Also called Nonsurgical periodontal therapy
Scaling and root planning performed with curettes and ultrasonic scalers under local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole | Experimental | Not described Receives: Drug: Metronidazole; Procedure: Scaling and root planning |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Procedure: Scaling and root planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
Defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.
Measured: 12 months
Secondary outcomes (1)
Attachment level
Defined as the distance from the CEJ to the bottom of the pocket/sulcus.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startAug 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Augusta University
- Investigators
- Cassiano K Rosing, DDS, PhD, Principal investigator, Federal University of Rio Grande do SulCristiano Susin, DDS, PhD, Principal investigator, Medical College of Georgia School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405365
- Sponsor's protocol ID
- CNPq-402335/2008-2
- Status last verified
- Aug 2010
- First submitted
- 23 Aug 2010
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Obesity on Nonsurgical Periodontal Treatment of Destructive Periodontal Diseases
- ClinicalTrials.gov ID
- NCT01405365
- Acronym / sponsor ID
- CNPq-402335/2008-2
- Conditions
- Periodontitis, Periodontal Diseases, Obesity
- Keywords
- Periodontitis, Periodontal diseases, Obesity, Metronidazole, Prognosis, Probing depth, Periodontal attachment loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Augusta University
- Study start
- Aug 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 29 Jul 2011 (estimated)
- 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 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
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:
- scaling and root planing + placebo
- scaling and root planing + metronidazole
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole | Experimental | Drug: Metronidazole, Procedure: Scaling and root planning |
| Placebo | Placebo comparator | Drug: Placebo, Procedure: Scaling and root planning |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Development of diabetes or other conditions that may impair periodontal healing
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 |
|---|---|---|
| MetronidazoleAlso: FlagylMetronidazole 400mg TID for 10 days | Drug | Metronidazole |
| PlaceboAlso: Inactive Substance, Inactive DrugPlacebo pill TID for 10 days | Drug | Placebo |
| Scaling and root planningAlso: Nonsurgical periodontal therapyScaling and root planning performed with curettes and ultrasonic scalers under local anesthesia | Procedure or surgery | Metronidazole, Placebo |
Primary outcome
Probing depth
Time frame: 12 months
Defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.
1 secondary outcome
Attachment level
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2011.
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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.
Cassiano K Rosing, DDS, PhD principal investigator
Federal University of Rio Grande do Sul
Cristiano Susin, DDS, PhD principal investigator
Medical College of Georgia School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metronidazole and Scaling and root planning in people with Periodontitis and Periodontal Diseases, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Jul 2011. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo J Gaio, DDS (55 51 9252 4577, dudagaio@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2011.