Periodontal DiseasesPhase 2EONSPTNCT01533792
Effect of Non-surgical Periodontal Treatment
A Phase 2 study testing Supra/subgingival scaling using periodontal curette scraping and Supra and subgingival scaling in people with Periodontal Diseases and Adverse Effects, run by Universidade Federal do Maranhão.
Trial summary
Objective: The objective of this research was to compare the effect of a single session supragingival scaling in a group of pregnant women with periodontal disease with a group that received supra and subgingival scaling. Read more about this study
- Who is it for?
- Ages 15 to 43 years, women only
- Conditions the study is for
- Periodontal Diseases, Adverse Effects
- What is being tested?
- Supra/subgingival scaling using periodontal curette scraping and Supra and subgingival scaling
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Dec 2010
- Phase
- Phase 2
- 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 15 to 43 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant women between 15 and 43 who had at least 4 teeth with probing depth ≥ 4 mm or clinical attachment loss ≥ 3 mm, with bleeding on probing in the same place.
Who cannot join
- Patients with systemic disease or who used medications that interfere in the etiological factors of periodontal disease in the last six months, who wore braces and / or prosthetic devices, and women smokers who did not complete treatment.
About this study
Official title: Effect of Non-surgical Periodontal Treatment on Pregnant Women With Periodontitis: a Randomized Clinical Trial
Objective: The objective of this research was to compare the effect of a single session supragingival scaling in a group of pregnant women with periodontal disease with a group that received supra and subgingival scaling.
Methods: The investigators included 34 pregnant women between 15 and 43 who had at least 4 teeth with probing depth ≥ 4 mm or clinical attachment loss ≥ 3 mm, with bleeding on probing in the same place. Women were divided into two groups, the group 1 received supra and subgingival scaling associated with oral hygiene orientation (OHO) and the group 2 received only supragingival scaling with OHO too.
- Conditions
- Periodontal Diseases, Adverse Effects
- Being tested
- Supra/subgingival scaling using periodontal curette scraping, Supra and subgingival scaling
- Keywords
- Treatment, pregnant women, periodontitis, dental scaling, dental plaque
- Medical subject headings
- Periodontal Diseases, Periodontitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supra/subgingival scaling using periodontal curette scrapingProcedure or surgery
The experimental group received supra and subgingival therapy with periodontal curettes
Supra and subgingival scalingProcedure or surgery
The experimental group received supra and subgingival scaling.
| Study group | Role | What they receive |
|---|---|---|
| Supra/subgingival therapy | Experimental | The experimental group received supra and subgingival scaling associated with oral hygiene orientation (OHO) Receives: Procedure: Supra/subgingival scaling using periodontal curette scraping; Procedure: Supra and subgingival scaling |
| Control group | Active comparator | Control group received only supragingival scaling with OHO too. Receives: Procedure: Supra/subgingival scaling using periodontal curette scraping; Procedure: Supra and subgingival scaling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of non-surgical periodontal treatment in pregnancy with periodontal disease
A single calibrated examiner performed clinical examination in pregnant women participating in the measurement of parameters: probing depth, clinical attachment level, hyperplasia, recession, bleeding, presence of plaque and tooth mobility on a standardized form.
Quantitative parameters were evaluated at six sites per tooth: mesio/medium/ distobuccal and mesio/medium/distolingual through millimeter periodontal probe-type Williams. The bleeding and the presence of plaque in dichotomous variables were measured: present and absent. All patients received oral hygiene orientation (OHO).
Measured: 30 days
Effect of non-surgical periodontal treatment in pregnancy with periodontitis
The patients were randomly divided by lottery into two groups. The group 1, termed SUPRA/SUB received OHO, supra and subgingival scraping and the group 2: SUPRA supragingival scraping and OHO. In both groups, the scaling procedure was performed using periodontal curettes type Mc Call 13-14 and 17-18 (DUFLEX) in one session.
Within 30 days after the initial session scraping clinical parameters were reevaluated, and now, according to every need, the patients were submitted to the supra and subgingival therapy. Noting that full dental care was provided to participants.
Measured: Assess periodontal disease at times: initial (when pregnancy arrived) and final (30 days after periodontal therapy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Maranhão
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielli Maria Zucateli Feitosa, Universidade Federal do Maranhão
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533792
- Sponsor's protocol ID
- UFMA-2011-DANI
- Acronym
- EONSPT
- Status last verified
- Feb 2012
- First submitted
- 28 Jan 2012
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-surgical Periodontal Treatment on Pregnant Women With Periodontitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01533792
- Acronym / sponsor ID
- EONSPT / UFMA-2011-DANI
- Conditions
- Periodontal Diseases, Adverse Effects
- Keywords
- Treatment, pregnant women, periodontitis, dental scaling, dental plaque
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Federal do MaranhãoUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Feb 2012 (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.
Objective: The objective of this research was to compare the effect of a single session supragingival scaling in a group of pregnant women with periodontal disease with a group that received supra and subgingival scaling.
Methods: The investigators included 34 pregnant women between 15 and 43 who had at least 4 teeth with probing depth ≥ 4 mm or clinical attachment loss ≥ 3 mm, with bleeding on probing in the same place. Women were divided into two groups, the group 1 received supra and subgingival scaling associated with oral hygiene orientation (OHO) and the group 2 received only supragingival scaling with OHO too.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supra/subgingival therapy | Experimental | Procedure: Supra/subgingival scaling using periodontal curette scraping, Procedure: Supra and subgingival scalingThe experimental group received supra and subgingival scaling associated with oral hygiene orientation (OHO) |
| Control group | Active comparator | Procedure: Supra/subgingival scaling using periodontal curette scraping, Procedure: Supra and subgingival scalingControl group received only supragingival scaling with OHO too. |
Who may qualify
- Ages
- 15 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pregnant women between 15 and 43 who had at least 4 teeth with probing depth ≥ 4 mm or clinical attachment loss ≥ 3 mm, with bleeding on probing in the same place.
Key exclusion criteria (1 listed)
- Patients with systemic disease or who used medications that interfere in the etiological factors of periodontal disease in the last six months, who wore braces and / or prosthetic devices, and women smokers who did not complete treatment.
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 |
|---|---|---|
| Supra/subgingival scaling using periodontal curette scrapingThe experimental group received supra and subgingival therapy with periodontal curettes | Procedure or surgery | Control group, Supra/subgingival therapy |
| Supra and subgingival scalingThe experimental group received supra and subgingival scaling. | Procedure or surgery | Control group, Supra/subgingival therapy |
Primary outcome
Effect of non-surgical periodontal treatment in pregnancy with periodontal disease
Time frame: 30 days
A single calibrated examiner performed clinical examination in pregnant women participating in the measurement of parameters: probing depth, clinical attachment level, hyperplasia, recession, bleeding, presence of plaque and tooth mobility on a standardized form. Quantitative parameters were evaluated at six sites per tooth: mesio/medium/ distobuccal and mesio/medium/distolingual through millimeter periodontal probe-type Williams. The bleeding and the presence of plaque in dichotomous variables were measured: present and absent. All patients received oral hygiene orientation (OHO).
Effect of non-surgical periodontal treatment in pregnancy with periodontitis
Time frame: Assess periodontal disease at times: initial (when pregnancy arrived) and final (30 days after periodontal therapy).
The patients were randomly divided by lottery into two groups. The group 1, termed SUPRA/SUB received OHO, supra and subgingival scraping and the group 2: SUPRA supragingival scraping and OHO. In both groups, the scaling procedure was performed using periodontal curettes type Mc Call 13-14 and 17-18 (DUFLEX) in one session. Within 30 days after the initial session scraping clinical parameters were reevaluated, and now, according to every need, the patients were submitted to the supra and subgingival therapy. Noting that full dental care was provided to participants.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Supra/subgingival scaling using periodontal curette scraping and Supra and subgingival scaling in people with Periodontal Diseases and Adverse Effects, run by Universidade Federal do Maranhão.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of non-surgical periodontal treatment in pregnancy with periodontal disease (time frame: 30 days). The study lists 2 primary outcomes in all. 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 17 Feb 2012.