PeriodontitisPhase 3OPTNCT00066131
Obstetrics and Periodontal Therapy (OPT) Study
A Phase 3 study testing Periodontal scaling and root planing and Scaling and root planing in people with Periodontitis and Infant, Premature, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to determine if non-surgical periodontal (gum) treatment can reduce the incidence of preterm birth and low birth weight babies in mothers with periodontitis (gum disease). Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Periodontitis, Infant, Premature
- What is being tested?
- Periodontal scaling and root planing and Scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 823 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Feb 2006
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be pregnant in the first 13-16 weeks of gestation as determined by menstrual history and obstetrical ultrasound
- Be at least 16 years of age
- Have at least 20 natural teeth,
- Have bleeding on probing (BOP) on at least 35% of all tooth sites
- Have 4 or more teeth with pockets greater than or equal to 4 mm and attachment loss greater than or equal to 2 mm
Who cannot join
- Are unable to provide informed consent or are unable to cooperate with the study protocol.
- May be placed at medical risk as a result of participation (i.e. subjects with hematologic disease or other disorders tha preclude routine non-surgical periodontal therapy).
- Have multiple fetuses as diagnosed by ultrasound.
- Require antibiotic prophylaxis for periodontal procedures
- Require greater than 3 essential dental care visits because of extensive decay and/or broken teeth and are likely to have less than 20 natural teeth following essential dental care
Trial locations and contacts
1 site in 1 country.
United States1 site
Univerisity of Minnesota School Of Dentistry
Minneapolis, Minnesota, 55455
About this study
Official title: Effects of Periodontal Therapy on Preterm Birth
The purpose of this study is to determine if non-surgical periodontal (gum) treatment can reduce the incidence of preterm birth and low birth weight babies in mothers with periodontitis (gum disease).
Read the detailed description
Eight hundred sixteen women who are between 13 and 16 weeks pregnant will be enrolled in this trial. Volunteers will be recruited from Hennepin County Medical Center (MN), the Jackson Medical Mall (MS), the University of Kentucky, and Harlem (NY) Hospital. The incidence of preterm birth is higher at these sites than the national average. Subjects will be randomly assigned to receive non-surgical mechanical periodontal therapy (scaling and root planing) either prior to 20 weeks of their pregnancy or soon after delivery. All subjects will be monitored for progressive periodontitis and will be treated immediately regardless of their group assignment. All women will also receive essential dental care to restore caries and treat abscessed teeth. The primary birth outcome is gestational age at birth and the secondary outcome is birthweight. Maternal risk factors for preterm birth and/or intrauterine growth restriction will be used as covariates in the data analysis. The study will also document the effect of periodontal therapy on immune response, systemic markers of inflammation, periodontal infection and clinical periodontal measure.
- Conditions
- Periodontitis, Infant, Premature
- Being tested
- Periodontal scaling and root planing, Scaling and root planing
- Medical subject headings
- Periodontitis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal scaling and root planingProcedure or surgery
Also called Deep cleaning
Hard and soft tisse deposits (plaque and calculus) are removed from the tooth and tooth root using hand and ultrasonic instruments.
Scaling and root planingProcedure or surgery
Delivered using hand and powered scalers and with topical or local (injected) anesthetics as needed. Procedures performed over 1 to 4 90-minute visits.
| Study group | Role | What they receive |
|---|---|---|
| Scaling and root planing | Active comparator | Scaling and root planing delivered prior to 21 weeks of gestation. Receives: Procedure: Periodontal scaling and root planing; Procedure: Scaling and root planing |
| Placebo | No intervention | Delayed treatment group. Controls monitored clinically from baseline to 29-32 weeks of gestation. Scaling and root planing provided after delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age at birth
Measured: At delivery
Secondary outcomes (4)
Infant birth weight
Measured: At delivery
Periodontal probing depth
Measured: 29-32 weeks of gestation
Clinical attachment loss
Measured: 29-32 weeks of gestation
Bleeding following periodontal probing
Measured: 29-32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2003 (estimated)
- Study startMar 2003
- Primary completionDec 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 823 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Panos Papapanou, DDS, PhD, Study director, Harlem HospitalAnthony DiAngelis, DMD, Study director, Hennepin County Medical Center, MinneapolisWilliam Buchanan, DDS, Study director, Jackson Medical MallJohn Novak, DDS, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066131
- Sponsor's protocol ID
- 0104M94001
- Other IDs
- NIDCR-DE014338
- Acronym
- OPT
- Status last verified
- Jul 2015
- First submitted
- 4 Aug 2003
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Michalowicz BS, Hodges JS, DiAngelis AJ, Lupo VR, Novak MJ, Ferguson JE, Buchanan W, Bofill J, Papapanou PN, Mitchell DA, Matseoane S, Tschida PA; OPT Study. Treatment of periodontal disease and the risk of preterm birth. N Engl J Med. 2006 Nov 2;355(18):1885-94. doi: 10.1056/NEJMoa062249.
PubMed 17079762
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Periodontal Therapy on Preterm Birth
- ClinicalTrials.gov ID
- NCT00066131
- Acronym / sponsor ID
- OPT / 0104M94001
- Conditions
- Periodontitis, Infant, Premature
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 823 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Mar 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 5 Aug 2003 (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 determine if non-surgical periodontal (gum) treatment can reduce the incidence of preterm birth and low birth weight babies in mothers with periodontitis (gum disease).
Detailed description
Eight hundred sixteen women who are between 13 and 16 weeks pregnant will be enrolled in this trial. Volunteers will be recruited from Hennepin County Medical Center (MN), the Jackson Medical Mall (MS), the University of Kentucky, and Harlem (NY) Hospital. The incidence of preterm birth is higher at these sites than the national average. Subjects will be randomly assigned to receive non-surgical mechanical periodontal therapy (scaling and root planing) either prior to 20 weeks of their pregnancy or soon after delivery. All subjects will be monitored for progressive periodontitis and will be treated immediately regardless of their group assignment. All women will also receive essential dental care to restore caries and treat abscessed teeth. The primary birth outcome is gestational age at birth and the secondary outcome is birthweight. Maternal risk factors for preterm birth and/or intrauterine growth restriction will be used as covariates in the data analysis. The study will also document the effect of periodontal therapy on immune response, systemic markers of inflammation, periodontal infection and clinical periodontal measure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scaling and root planing | Active comparator | Procedure: Periodontal scaling and root planing, Procedure: Scaling and root planingScaling and root planing delivered prior to 21 weeks of gestation. |
| Placebo | No intervention | –Delayed treatment group. Controls monitored clinically from baseline to 29-32 weeks of gestation. Scaling and root planing provided after delivery. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Be pregnant in the first 13-16 weeks of gestation as determined by menstrual history and obstetrical ultrasound
- Be at least 16 years of age
- Have at least 20 natural teeth,
- Have bleeding on probing (BOP) on at least 35% of all tooth sites
- Have 4 or more teeth with pockets greater than or equal to 4 mm and attachment loss greater than or equal to 2 mm
Key exclusion criteria (5 listed)
- Are unable to provide informed consent or are unable to cooperate with the study protocol.
- May be placed at medical risk as a result of participation (i.e. subjects with hematologic disease or other disorders tha preclude routine non-surgical periodontal therapy).
- Have multiple fetuses as diagnosed by ultrasound.
- Require antibiotic prophylaxis for periodontal procedures
- Require greater than 3 essential dental care visits because of extensive decay and/or broken teeth and are likely to have less than 20 natural teeth following essential dental care
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 |
|---|---|---|
| Periodontal scaling and root planingAlso: Deep cleaningHard and soft tisse deposits (plaque and calculus) are removed from the tooth and tooth root using hand and ultrasonic instruments. | Procedure or surgery | Scaling and root planing |
| Scaling and root planingDelivered using hand and powered scalers and with topical or local (injected) anesthetics as needed. Procedures performed over 1 to 4 90-minute visits. | Procedure or surgery | Scaling and root planing |
Primary outcome
Gestational age at birth
Time frame: At delivery
4 secondary outcomes
Infant birth weight
Time frame: At delivery
Periodontal probing depth
Time frame: 29-32 weeks of gestation
Clinical attachment loss
Time frame: 29-32 weeks of gestation
Bleeding following periodontal probing
Time frame: 29-32 weeks
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 27 Jul 2015.
- Results publication: PubMed 17079762Michalowicz BS, Hodges JS, DiAngelis AJ, Lupo VR, Novak MJ, Ferguson JE, Buchanan W, Bofill J, Papapanou PN, Mitchell DA, Matseoane S, Tschida PA; OPT Study. Treatment of periodontal disease and the risk of preterm birth. N Engl J Med. 2006 Nov 2;355(18):1885-94. doi: 10.1056/NEJMoa062249.
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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.
Panos Papapanou, DDS, PhD study director
Harlem Hospital
Anthony DiAngelis, DMD study director
Hennepin County Medical Center, Minneapolis
William Buchanan, DDS study director
Jackson Medical Mall
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Periodontal scaling and root planing and Scaling and root planing in people with Periodontitis and Infant, Premature, run by University of Minnesota at 1 site in United States.
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 5 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 27 Jul 2015. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Gestational age at birth (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00066131, which also lists 1 linked publication.
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 27 Jul 2015.