Periodontal DiseaseNCT00893802
Influence of Periodontal Treatment During Pregnancy in Adverse Pregnant Outcomes
A study testing Scaling and root planning in people with Periodontal Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the effects of treatment of periodontal disease during the second trimester of gestation in adverse pregnancy outcomes. Pregnant patients during the 1st and 2nd trimesters at antenatal care in a Public Health Center will be divided into two groups: NIG- 'no intervention' or IG… Read more about this study
- Who is it for?
- Ages 16 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- Scaling and root planning
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2001to Sep 2002
- 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 16 to 39 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- confirmed singleton gestations
- pregnancy of 9-24
- systemically healthy women
- age range: 16-39 years old
Who cannot join
- non confirmed pregnancy
- age inferior to 16 years or superior to 39 years
- multiple gestations
- smoking
- alcohol or drugs abuse
- history of congenital heart disease
- current use of corticosteroids or antibiotics
- presence of systemic conditions (eg: diabetes, hypertension, or genitor-urinary infections)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Jardim Redentor I Public Health Center
Bauru, São Paulo, 17100-000
About this study
Official title: Influence of Periodontal Treatment in Pregnant Women Attending Antenatal Care at a Public Health Center in Adverse Pregnant Outcomes: a Controlled Clinical Trial
The aim of this study is to evaluate the effects of treatment of periodontal disease during the second trimester of gestation in adverse pregnancy outcomes.
Pregnant patients during the 1st and 2nd trimesters at antenatal care in a Public Health Center will be divided into two groups: NIG- 'no intervention' or IG- 'intervention,' according to agreement in receive periodontal treatment during pregnancy. Treatment will be performed by a single periodontist consisting of scaling and root planning (SRP), professional prophylaxis (PROPH) and oral hygiene instruction (OHI). Patients at NIG will receive PROPH and OHI during pregnancy and will be referred for treatment after delivery. Periodontal evaluation will be performed by a single trained examiner, blinded to periodontal treatment, according to probing depth (PD), clinical attachment level (CAL), plaque index (PI) and sulcular bleeding index (SBI) at baseline and 35 gestational weeks-28 days post-partum. Primary adverse pregnancy outcomes to be addressed are: preterm birth (< 37 weeks), low birth weight (< 2.500 Kg), late abortion (14-24 weeks) or abortion (< 14 weeks). The results obtained will be statistically evaluated according to OR, unpaired t test and paired t test.
It is expected that periodontal treatment during the second trimester of gestation will result in decreased rates of adverse pregnancy outcomes.
Read the detailed description
All patients entering the study at the 1st and 2nd trimesters will be invited to participate in an oral health program, including oral hygiene instruction, caries diagnosis and treatment, and evaluation and treatment of periodontal conditions during the second trimester. Those who refuse to receive periodontal treatment during pregnancy will constitute the 'no intervention' control group (NIG), while those who agree in receiving dental and periodontal treatment during the second trimester of gestation will constitute the 'intervention' group (IG).
Patients are going to be evaluated by a single calibrated periodontist blinded in relation to periodontal treatment, which will be performed by another periodontist. Treatment consists of scaling and root planning, professional prophylaxis and oral hygiene instruction. Obstetrical data, birth weight and gestation duration will be recorded after examination and recording by the responsible obstetrician and nursery staff.
- Conditions
- Periodontal Disease
- Being tested
- Scaling and root planning
- Keywords
- periodontal disease, pregnancy, periodontal treatment
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planningOther
Intervention will consist of supra and subgingival scaling and root planning performed by a single trained periodontist using Gracey curettes (Hu-Friedy, Chicago, USA) without local or general anesthesia during the second trimester of gestation, followed by professional prophylaxis and oral hygiene instruction. Treatment will be performed only once during study.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal treatment | Experimental | Scaling and root planning Receives: Other: Scaling and root planning |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measures recorded are: preterm birth (PTB), defined as delivery < 37 weeks; low birth weight (LBW), defined as < 2.500Kg birth weight; preterm birth and low birth weight
Measured: Within 30 days after delivery
Secondary outcomes (1)
Secondary outcome measures are: late abortion (14-24 gestational weeks); and abortion (< 14 gestational weeks)
Measured: Within 30 days after development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startAug 2001
- Primary completionAug 2002
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Adriana P Sant'Ana, DDS PhD, Study director, Associate Professor - School of Dentistry at Bauru-USPMarinele R Campos, DDS, Principal investigator, Graduation student on Periodontics (Master level). School of Dentistry at Bauru - USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893802
- Sponsor's protocol ID
- CEP102/2002/FOB
- Other IDs
- CEP 102/2002
- Status last verified
- May 2009
- First submitted
- 4 May 2009
- Last updated
- 6 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Periodontal Treatment in Pregnant Women Attending Antenatal Care at a Public Health Center in Adverse Pregnant Outcomes: a Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00893802
- Acronym / sponsor ID
- CEP102/2002/FOB
- Conditions
- Periodontal Disease
- Keywords
- periodontal disease, pregnancy, periodontal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2001
- Primary completion
- Aug 2002 (actual)
- Study completion
- Sep 2002 (actual)
- First posted
- 6 May 2009 (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 aim of this study is to evaluate the effects of treatment of periodontal disease during the second trimester of gestation in adverse pregnancy outcomes.
Pregnant patients during the 1st and 2nd trimesters at antenatal care in a Public Health Center will be divided into two groups: NIG- 'no intervention' or IG- 'intervention,' according to agreement in receive periodontal treatment during pregnancy. Treatment will be performed by a single periodontist consisting of scaling and root planning (SRP), professional prophylaxis (PROPH) and oral hygiene instruction (OHI). Patients at NIG will receive PROPH and OHI during pregnancy and will be referred for treatment after delivery. Periodontal evaluation will be performed by a single trained examiner, blinded to periodontal treatment, according to probing depth (PD), clinical attachment level (CAL), plaque index (PI) and sulcular bleeding index (SBI) at baseline and 35 gestational weeks-28 days post-partum. Primary adverse pregnancy outcomes to be addressed are: preterm birth (< 37 weeks), low birth weight (< 2.500 Kg), late abortion (14-24 weeks) or abortion (< 14 weeks). The results obtained will be statistically evaluated according to OR, unpaired t test and paired t test.
It is expected that periodontal treatment during the second trimester of gestation will result in decreased rates of adverse pregnancy outcomes.
Detailed description
All patients entering the study at the 1st and 2nd trimesters will be invited to participate in an oral health program, including oral hygiene instruction, caries diagnosis and treatment, and evaluation and treatment of periodontal conditions during the second trimester. Those who refuse to receive periodontal treatment during pregnancy will constitute the 'no intervention' control group (NIG), while those who agree in receiving dental and periodontal treatment during the second trimester of gestation will constitute the 'intervention' group (IG).
Patients are going to be evaluated by a single calibrated periodontist blinded in relation to periodontal treatment, which will be performed by another periodontist. Treatment consists of scaling and root planning, professional prophylaxis and oral hygiene instruction. Obstetrical data, birth weight and gestation duration will be recorded after examination and recording by the responsible obstetrician and nursery staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontal treatment | Experimental | Other: Scaling and root planningScaling and root planning |
| Control | No intervention | – |
Who may qualify
- Ages
- 16 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- confirmed singleton gestations
- pregnancy of 9-24
- systemically healthy women
- age range: 16-39 years old
Key exclusion criteria (8 listed)
- non confirmed pregnancy
- age inferior to 16 years or superior to 39 years
- multiple gestations
- smoking
- alcohol or drugs abuse
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 |
|---|---|---|
| Scaling and root planningIntervention will consist of supra and subgingival scaling and root planning performed by a single trained periodontist using Gracey curettes (Hu-Friedy, Chicago, USA) without local or general anesthesia during the second trimester of gestation, followed by professional prophylaxis and oral hygiene instruction. Treatment will be performed only once during study. | Other | Periodontal treatment |
Primary outcome
Primary outcome measures recorded are: preterm birth (PTB), defined as delivery < 37 weeks; low birth weight (LBW), defined as < 2.500Kg birth weight; preterm birth and low birth weight
Time frame: Within 30 days after delivery
1 secondary outcome
Secondary outcome measures are: late abortion (14-24 gestational weeks); and abortion (< 14 gestational weeks)
Time frame: Within 30 days after development
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 6 May 2009.
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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.
Adriana P Sant'Ana, DDS PhD study director
Associate Professor - School of Dentistry at Bauru-USP
Marinele R Campos, DDS principal investigator
Graduation student on Periodontics (Master level). School of Dentistry at Bauru - USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planning in people with Periodontal Disease, run by University of Sao Paulo 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 4 inclusion and 8 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 6 May 2009. 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. 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?
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?
Primary outcome measures recorded are: preterm birth (PTB), defined as delivery < 37 weeks; low birth weight (LBW), defined as < 2.500Kg birth weight; preterm birth and low birth weight (time frame: Within 30 days after delivery). 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 6 May 2009.