PregnancyNCT02613468
Periodontal Condition in Pregnancy and Low Birth Delivery Incidence
A study testing collection of periodontal records, pregnancy parameters and Initial Periodontal Therapy in people with Pregnancy and Birth Weight, run by Ondokuz Mayıs University.
Trial summary
The objective of this study was the evaluation of periodontal condition in pregnant women and the effect of the treatment of periodontal disease upon low birth weight. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Birth Weight, Periodontal Diseases
- What is being tested?
- collection of periodontal records, pregnancy parameters and Initial Periodontal Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 269 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Aug 2005
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age:18-35 years
- Sure of her dates
Who cannot join
- systemic diseases (i.e., diabetes mellitus, cancer, hypertension, urolithiasis, parathyroid disease, diseases that compromise pregnancy)
- Less than two pregnancy
About this study
Official title: A Comparative Evaluation in Pregnant Women of the Periodontal Condition and Low Birth Delivery Incidence
The objective of this study was the evaluation of periodontal condition in pregnant women and the effect of the treatment of periodontal disease upon low birth weight.
Read the detailed description
This research was carried out in the following three centers: Samsun Birth and Children's Hospital, Department of Obstetrics and Gynecology of the Faculty of Medicine and Faculty of Dentistry of the University of Ondokuz Mayıs. 269 women in their first trimester were included in this study. Their ages ranged from 18-35 years, their height was above 150 cm and they have no history of any systemic disease. At the end of each trimester these measurements were performed: attachment level, probing depth, gingival index, plaque index, and bleeding on probing. According to the periodontal diagnosis the research population was divided into three groups: periodontally healthy women; periodontally diseased women, however rejection of treatment; periodontally diseased women, however acceptance of treatment.In this study one-way ANOVA, chi-square, conditional logistic regression analyses were used.
- Conditions
- Pregnancy, Birth Weight, Periodontal Diseases
- Being tested
- collection of periodontal records, pregnancy parameters, Initial Periodontal Therapy
- Keywords
- Pregnancy, Low birth weight, Gingivitis, Inflammation, Periodontitis
- Medical subject headings
- Birth Weight, Periodontal Diseases, Gingivitis, Inflammation, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of periodontal recordsOther
- Clinic attachment level
- Probing depth
- Gingival index
- Plaque index
- Bleeding on probing were performed in all groups. These measurements were performed at the end of each trimester.
pregnancy parametersOther
Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit and birth weight were evaluated.
Initial Periodontal TherapyOther
Initial Periodontal Therapy is completed ( Supragingival and subgingival calculus elimination, root planning, polishing etc.) This treatment is considered to be the safest time for pregnant mothers was performed in 2 trimester.
| Study group | Role | What they receive |
|---|---|---|
| Periodontally healthy | Placebo comparator | Some periodontal measurements (attachment level, probing depth, gingival index, plaque index, and bleeding on probing) were performed in periodontally healthy pregnant. These measurements were performed at the end of each trimester.
Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit and birth weight were evaluated.
Intervation: Collection of periodontal records and pregnancy parameters. Receives: Other: collection of periodontal records; Other: pregnancy parameters |
| Periodontally diseased, untreated | Placebo comparator | This group is comprised of individuals who do not accept treatment Some periodontal measurements (attachment level, probing depth, gingival index, plaque index, and bleeding on probing) were performed in periodontally healthy pregnant. These measurements were performed at the end of each trimester.
Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit were evaluated.
Birth weight was recorded at the end of pregnancy. Receives: Other: collection of periodontal records; Other: pregnancy parameters |
| Periodontally diseased, treated | Active comparator | This group is comprised of individuals who agree to treatment. Some periodontal measurements (attachment level, probing depth, gingival index, plaque index, and bleeding on probing) were performed in periodontally healthy pregnant. These measurements were performed at the end of each trimester.
Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit were evaluated.
Initial Periodontal Therapy is completed (calculus elimination, root planning, polishing etc.) This treatment is considered to be the safest time for pregnant mothers was performed in 2 trimester.
Birth weight was recorded at the end of pregnancy. Intervation: Collection of periodontal records and pregnancy parameters. Receives: Other: collection of periodontal records; Other: pregnancy parameters; Other: Initial Periodontal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pregnancies
Number of pregnancies (numbers)
Measured: At 9th months
Birth weight
Birth weight (kg)
Measured: At 9th months
Secondary outcomes (5)
Probing pocket depth
The changes in probing pocket depth in time frame.Probing pocket depth was measured for determining severity of disease and clinic outcome.
Measured: average of 2nd months, 5th months and 8th months
Clinical attachment level
The changes in clinical attachment level in time frame. Clinical attachment level was measured for determining severity of disease and clinic outcome.
Measured: average of 2nd months, 5th months and 8th months
Gingival index
The changes in gingival index in time frame. Gingival index was recorded for classifying and evaluating (coronally) gingival inflammation.
Measured: average of 2nd months, 5th months and 8th months
Plaque index
The changes in plaque index in time frame. Plaque index was recorded for determining and classifying oral hygiene status.
Measured: average of 2nd months, 5th months and 8th months
Bleeding on probing
The changes in bleeding on probing in time frame. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.
Measured: average of 2nd months, 5th months and 8th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startJan 2004
- Primary completionDec 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İnci Devrim, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613468
- Sponsor's protocol ID
- OndokusMu
- Status last verified
- Nov 2015
- First submitted
- 13 Nov 2015
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation in Pregnant Women of the Periodontal Condition and Low Birth Delivery Incidence
- ClinicalTrials.gov ID
- NCT02613468
- Acronym / sponsor ID
- OndokusMu
- Conditions
- Pregnancy, Birth Weight, Periodontal Diseases
- Keywords
- Pregnancy, Low birth weight, Gingivitis, Inflammation, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 24 Nov 2015 (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 objective of this study was the evaluation of periodontal condition in pregnant women and the effect of the treatment of periodontal disease upon low birth weight.
Detailed description
This research was carried out in the following three centers: Samsun Birth and Children's Hospital, Department of Obstetrics and Gynecology of the Faculty of Medicine and Faculty of Dentistry of the University of Ondokuz Mayıs. 269 women in their first trimester were included in this study. Their ages ranged from 18-35 years, their height was above 150 cm and they have no history of any systemic disease. At the end of each trimester these measurements were performed: attachment level, probing depth, gingival index, plaque index, and bleeding on probing. According to the periodontal diagnosis the research population was divided into three groups: periodontally healthy women; periodontally diseased women, however rejection of treatment; periodontally diseased women, however acceptance of treatment.In this study one-way ANOVA, chi-square, conditional logistic regression analyses were used.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Periodontally healthy | Placebo comparator | Other: collection of periodontal records, Other: pregnancy parametersSome periodontal measurements (attachment level, probing depth, gingival index, plaque index, and bleeding on probing) were performed in periodontally healthy pregnant. These measurements were performed at the end of each trimester. Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit and birth weight were evaluated. Intervation: Collection of periodontal records and pregnancy parameters. |
| Periodontally diseased, untreated | Placebo comparator | Other: collection of periodontal records, Other: pregnancy parametersThis group is comprised of individuals who do not accept treatment Some periodontal measurements (attachment level, probing depth, gingival index, plaque index, and bleeding on probing) were performed in periodontally healthy pregnant. These measurements were performed at the end of each trimester. Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit were evaluated. Birth weight was recorded at the end of pregnancy. |
| Periodontally diseased, treated | Active comparator | Other: collection of periodontal records, Other: pregnancy parameters, Other: Initial Periodontal TherapyThis group is comprised of individuals who agree to treatment. Some periodontal measurements (attachment level, probing depth, gingival index, plaque index, and bleeding on probing) were performed in periodontally healthy pregnant. These measurements were performed at the end of each trimester. Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit were evaluated. Initial Periodontal Therapy is completed (calculus elimination, root planning, polishing etc.) This treatment is considered to be the safest time for pregnant mothers was performed in 2 trimester. Birth weight was recorded at the end of pregnancy. Intervation: Collection of periodontal records and pregnancy parameters. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age:18-35 years
- Sure of her dates
Key exclusion criteria (2 listed)
- systemic diseases (i.e., diabetes mellitus, cancer, hypertension, urolithiasis, parathyroid disease, diseases that compromise pregnancy)
- Less than two pregnancy
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 |
|---|---|---|
| collection of periodontal records1. Clinic attachment level 2. Probing depth 3. Gingival index 4. Plaque index 5. Bleeding on probing were performed in all groups. These measurements were performed at the end of each trimester. | Other | Periodontally diseased, treated, Periodontally diseased, untreated, Periodontally healthy |
| pregnancy parametersParameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit and birth weight were evaluated. | Other | Periodontally diseased, treated, Periodontally diseased, untreated, Periodontally healthy |
| Initial Periodontal TherapyInitial Periodontal Therapy is completed ( Supragingival and subgingival calculus elimination, root planning, polishing etc.) This treatment is considered to be the safest time for pregnant mothers was performed in 2 trimester. | Other | Periodontally diseased, treated |
Primary outcome
Number of pregnancies
Time frame: At 9th months
Number of pregnancies (numbers)
Birth weight
Time frame: At 9th months
Birth weight (kg)
5 secondary outcomes
Probing pocket depth
Time frame: average of 2nd months, 5th months and 8th months
Clinical attachment level
Time frame: average of 2nd months, 5th months and 8th months
Gingival index
Time frame: average of 2nd months, 5th months and 8th months
Plaque index
Time frame: average of 2nd months, 5th months and 8th months
Bleeding on probing
Time frame: average of 2nd months, 5th months and 8th months
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 25 Nov 2015.
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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 study testing collection of periodontal records, pregnancy parameters and Initial Periodontal Therapy in people with Pregnancy and Birth Weight, run by Ondokuz Mayıs University.
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 2 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: finished, as of the sponsor's last update on 25 Nov 2015. 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. 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?
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?
Number of pregnancies (time frame: At 9th months). 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 25 Nov 2015.