Birth WeightNSPTNCT03126006
The Effect of Non-surgical Periodontal Therapy on Adverse Birth Outcomes Randomized Controlled Trial
A study testing NSPT plus oral hygiene and Oral hygiene alone in people with Birth Weight and Birth, Preterm, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The main objective of this study is to determine whether the provision of non-surgical periodontal therapy to pregnant women with periodontitis is effective in reducing the incidence of low birth weight, preterm birth and still birth when compared to pregnant women with periodontitis but who will be provided with oral… 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
- Birth Weight, Birth, Preterm
- What is being tested?
- NSPT plus oral hygiene and Oral hygiene alone
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2015to 1 Sep 2017
- 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
- Pregnant woman presenting to the Obstetric clinic at the Aga Khan Hospital for Women, Karimabad or the Aga Khan Hospital for Women and Children, Kharadar.
- Participant should be between the ages of 18 and 35 years
- Exhibiting at least 2 sites with 2mm or more periodontal probing depth.
- Planning to deliver the baby at the above mentioned facilities so that the outcome can be observed and measured.
- Singleton pregnancy.
- Willing to get NSPT done between 20 to 28 weeks of gestation.
- At least 20 teeth present in the mouth so that periodontal scoring could be done.
Who cannot join
- Tobacco or alcohol use.
- Genitourinary tract infection or any systemic infection.
- Obstetric disorders such as gestational diabetes or placenta previa or pre-eclampsia or eclampsia etc.
- Chronic disease such as diabetes or blood pressure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Non-surgical Periodontal Therapy on Adverse Birth Outcomes: A Randomized Controlled Trial
The main objective of this study is to determine whether the provision of non-surgical periodontal therapy to pregnant women with periodontitis is effective in reducing the incidence of low birth weight, preterm birth and still birth when compared to pregnant women with periodontitis but who will be provided with oral hygiene instructions alone.
Read the detailed description
Approximately two-thirds of pregnant Pakistani women suffer from periodontal disease a common inflammatory disease of the soft tissues surrounding the tooth. It was demonstrated that periodontitis among pregnant women is significantly associated with preterm birth and low birth weight. Pakistan has a high prevalence of these adverse birth outcomes therefore; identifying an intervention is of prime importance and may have social and economic benefits.
Non-surgical periodontal therapy is affordable and amenable to people and thus seems to be an intervention which may prove to be of benefit in a population where the dental services are available. It has been recommended in systematic reviews and Meta analysis that Randomized Controlled Trials are now required to establish whether the removal of inflammatory factors by scaling and root planning are effective in reducing adverse pregnancy outcomes such as preterm birth and low birth weight.
- Conditions
- Birth Weight, Birth, Preterm
- Being tested
- NSPT plus oral hygiene, Oral hygiene alone
- Medical subject headings
- Birth Weight, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSPT plus oral hygieneProcedure or surgery
Also called scaling, dental scaling, de-scaling, periodontal prophylaxis, periodontal debridement
Non-surgical periodontal therapy under local anesthesia to remove plaque and calculus
Oral hygiene aloneOther
It includes pregnant women (with periodontal disease) who will not be given any mechanical treatment such as non-surgical periodontal therapy during pregnancy. However, oral hygiene instructions will be given.
| Study group | Role | What they receive |
|---|---|---|
| NSPT plus oral hygiene | Experimental | It includes pregnant women (with periodontal disease) who will be subjected to one episode of non-surgical periodontal therapy under local anesthesia during pregnancy. they will receive oral hygiene instruction also. Receives: Procedure: NSPT plus oral hygiene |
| Oral hygiene alone | Other | It includes pregnant women (with periodontal disease) who will not be given any mechanical treatment such as non-surgical periodontal therapy during pregnancy. However, oral hygiene instructions will be given. Receives: Other: Oral hygiene alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature birth
less than 37 weeks
Measured: To be assessed at birth
Secondary outcomes (2)
Birth weight
less than 2500grams
Measured: To be assessed at birth
Still birth
To be assessed by the birth attendant/ Obgyne
Measured: To be assessed at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Feb 2015
- Primary completion1 Aug 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth WeightStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It's an assessor blinded, parallel group, randomized controlled trial aimed at determining the superiority of non-surgical periodontal therapy over no dental treatment among pregnant women. The main objective of this trial is to determine whether the provision of NSPT to pregnant women with periodontitis is effective in reducing the incidence of low birth weight, preterm birth and still birth when compared to the pregnant women who were subjected to no NSPT. Outcomes of interest are pre-term birth (\<37 weeks) gestation, low birth weight (\<2500g) or still birth with either one occurring being considered as a positive outcome.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farhan Raza Khan, Aga Khan University
- Investigators
- Zaubina U Kazi, BDS, MSc, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126006
- Sponsor's protocol ID
- 3232-CHS-ERC-14
- Acronym
- NSPT
- Status last verified
- Jun 2018
- First submitted
- 19 Apr 2017
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-surgical Periodontal Therapy on Adverse Birth Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03126006
- Acronym / sponsor ID
- NSPT / 3232-CHS-ERC-14
- Conditions
- Birth Weight, Birth, Preterm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 24 Apr 2017 (actual)
- 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 main objective of this study is to determine whether the provision of non-surgical periodontal therapy to pregnant women with periodontitis is effective in reducing the incidence of low birth weight, preterm birth and still birth when compared to pregnant women with periodontitis but who will be provided with oral hygiene instructions alone.
Detailed description
Approximately two-thirds of pregnant Pakistani women suffer from periodontal disease a common inflammatory disease of the soft tissues surrounding the tooth. It was demonstrated that periodontitis among pregnant women is significantly associated with preterm birth and low birth weight. Pakistan has a high prevalence of these adverse birth outcomes therefore; identifying an intervention is of prime importance and may have social and economic benefits.
Non-surgical periodontal therapy is affordable and amenable to people and thus seems to be an intervention which may prove to be of benefit in a population where the dental services are available. It has been recommended in systematic reviews and Meta analysis that Randomized Controlled Trials are now required to establish whether the removal of inflammatory factors by scaling and root planning are effective in reducing adverse pregnancy outcomes such as preterm birth and low birth weight.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- It's an assessor blinded, parallel group, randomized controlled trial aimed at determining the superiority of non-surgical periodontal therapy over no dental treatment among pregnant women. The main objective of this trial is to determine whether the provision of NSPT to pregnant women with periodontitis is effective in reducing the incidence of low birth weight, preterm birth and still birth when compared to the pregnant women who were subjected to no NSPT. Outcomes of interest are pre-term birth (<37 weeks) gestation, low birth weight (<2500g) or still birth with either one occurring being considered as a positive outcome.
| Arm | Type | Receives |
|---|---|---|
| NSPT plus oral hygiene | Experimental | Procedure: NSPT plus oral hygieneIt includes pregnant women (with periodontal disease) who will be subjected to one episode of non-surgical periodontal therapy under local anesthesia during pregnancy. they will receive oral hygiene instruction also. |
| Oral hygiene alone | Other | Other: Oral hygiene aloneIt includes pregnant women (with periodontal disease) who will not be given any mechanical treatment such as non-surgical periodontal therapy during pregnancy. However, oral hygiene instructions will be given. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant woman presenting to the Obstetric clinic at the Aga Khan Hospital for Women, Karimabad or the Aga Khan Hospital for Women and Children, Kharadar.
- Participant should be between the ages of 18 and 35 years
- Exhibiting at least 2 sites with 2mm or more periodontal probing depth.
- Planning to deliver the baby at the above mentioned facilities so that the outcome can be observed and measured.
- Singleton pregnancy.
Key exclusion criteria (4 listed)
- Tobacco or alcohol use.
- Genitourinary tract infection or any systemic infection.
- Obstetric disorders such as gestational diabetes or placenta previa or pre-eclampsia or eclampsia etc.
- Chronic disease such as diabetes or blood pressure.
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 |
|---|---|---|
| NSPT plus oral hygieneAlso: scaling, dental scaling, de-scaling, periodontal prophylaxis, periodontal debridementNon-surgical periodontal therapy under local anesthesia to remove plaque and calculus | Procedure or surgery | NSPT plus oral hygiene |
| Oral hygiene aloneIt includes pregnant women (with periodontal disease) who will not be given any mechanical treatment such as non-surgical periodontal therapy during pregnancy. However, oral hygiene instructions will be given. | Other | Oral hygiene alone |
Primary outcome
Premature birth
Time frame: To be assessed at birth
less than 37 weeks
2 secondary outcomes
Birth weight
Time frame: To be assessed at birth
Still birth
Time frame: To be assessed at birth
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 28 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Zaubina U Kazi, BDS, MSc principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSPT plus oral hygiene and Oral hygiene alone in people with Birth Weight and Birth, Preterm, run by Aga Khan University at 1 site in Pakistan.
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 7 inclusion and 4 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 28 Jun 2018. 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 Pakistan. 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?
Premature birth (time frame: To be assessed at birth). 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 28 Jun 2018.