Plaque Induced GingivitisPREG_ORALNCT07896694
Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women
An observational study of Plaque Induced Gingivitis, run by Kurdistan Higher Council of Medical Specialties at 1 site in Iraq.
Trial summary
This study compares saliva characteristics and oral health status between pregnant and non-pregnant women. It evaluates salivary pH, buffering capacity, stimulated and unstimulated saliva flow rates, and oral health indicators, including dental caries, plaque, and gingival health. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Plaque Induced Gingivitis
- What is being tested?
- saliva analysis and oral health Assessment and Saliva assessment using the GC Saliva-Check Buffer kit to measure salivary pH and buffering capacity, alongside stimulated and unstimulated salivary flow rate measurements.
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteIraq
- Study dates
- 1 Mar 2026to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population consists of adult women aged 18 years and older, including pregnant and non-pregnant women. Pregnant participants are recruited from Erbil Maternity Hospital, while non-pregnant participants are recruited from Azadi Center. Eligible participants are included according to the study's inclusion and exclusion criteria.
Who may be able to join
- Healthy pregnant women at any trimester aged 18-40
- Healthy non-pregnant women in the same age group
- Women who are not using oral contraceptives.
- No history of radiation therapy to the head and neck region -
Who cannot join
- Women with systemic diseases or salivary gland disorders.
- Women taking medications that may affect saliva composition.
- Smokers or individuals with poor oral hygiene.
- Women who consumed food, drinks, or tobacco within one hour before sample collection.
- Participants with oral mucosal diseases.
- Individuals wearing orthodontic or partial prosthetic appliances -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Salivary Flow Rate, pH, Buffering Capacity, and Oral Health Status in Pregnant vs Non-Pregnant Women
This study compares saliva characteristics and oral health status between pregnant and non-pregnant women. It evaluates salivary pH, buffering capacity, stimulated and unstimulated saliva flow rates, and oral health indicators, including dental caries, plaque, and gingival health. The study aims to identify differences in saliva characteristics and oral health between the two groups and explore how these findings are associated with pregnancy. The results may help improve understanding of oral health needs during pregnancy and support better oral health education and preventive care for pregnant women. Participants undergo oral health examinations and saliva collection. No medication or treatment is being tested as part of this study.
Read the detailed description
Pregnancy is associated with physiological and hormonal changes that may be accompanied by changes in saliva characteristics and oral health. These changes may be associated with alterations in salivary pH, buffering capacity, and salivary flow, as well as differences in dental caries, plaque accumulation, and gingival health.
This study aims to compare saliva characteristics and oral health status between pregnant and non-pregnant women. The study evaluates salivary pH, buffering capacity, stimulated and unstimulated salivary flow rates, and oral health indicators. It also explores differences in these outcomes among pregnant women at different stages of pregnancy.
Participants undergo an oral health examination and saliva collection to assess the selected outcomes. The findings will provide information about the association between pregnancy, saliva characteristics, and oral health status.
The results may contribute to a better understanding of oral health needs during pregnancy and support the development of appropriate preventive dental care and oral health education strategies for pregnant women. The study is observational and does not involve testing a drug or providing an experimental treatment.
- Conditions
- Plaque Induced Gingivitis
- Being tested
- saliva analysis and oral health Assessment, Saliva assessment using the GC Saliva-Check Buffer kit to measure salivary pH and buffering capacity, alongside stimulated and unstimulated salivary flow rate measurements.
- Keywords
- pregnancy, oral health, saliva pH, plaque index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saliva analysis and oral health AssessmentOther
Assessment of salivary pH, buffering capacity, stimulated and unstimulated salivary flow rates, and oral health status through saliva collection and oral examination in pregnant and non-pregnant women.
Saliva assessment using the GC Saliva-Check Buffer kit to measure salivary pH and buffering capacity, alongside stimulated and unstimulated salivary flow rate measurements.Other
Not applicable. This is an observational comparative cross-sectional study with no intervention.
| Study group | Role | What they receive |
|---|---|---|
| group 1: Pregnant women | Not described | |
| group 1: Pregnant women group2: non-pregnant women | group 1 Pregnant women participating in the study undergo an oral health examination and saliva collection to assess salivary pH, buffering capacity, stimulated and unstimulated salivary flow rates, and oral health status. No intervention is administered group 2 Non-pregnant women participating in the study undergo an oral health examination and saliva collection to assess salivary pH, buffering capacity, stimulated and unstimulated salivary flow rates, and oral health status. No intervention is administered. Receives: Other: saliva analysis and oral health Assessment; Other: Saliva assessment using the GC Saliva-Check Buffer kit to measure salivary pH and buffering capacity, alongside stimulated and unstimulated salivary flow rate measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary pH
Comparison of salivary pH between pregnant and non-pregnant women.
Measured: Day 1 (at the study visit one assessment per participant)
Saliva buffering capacity
comparison of salivary buffering capacity scores between pregnant and non-pregnant women ,assessed using the GC saliva-check buffer kit
Measured: Day 1 (at the study visit one assessment per participant)
unstimulated salivary flow rate
comparison of unstimulated salivary flow rate between pregnant and non-pregnant women, measured by passive saliva collection over 5 minutes
Measured: Day 1 (at the study visit one assessment per participant)
stimulated salivary flow rate
comparison of stimulated salivary flow rates between pregnant and non-pregnant women following stimulation with paraffin wax and saliva collection over 5 minutes
Measured: Day 1 (at the study visit one assessment per participant)
Secondary outcomes (3)
Plaque index
Comparison of plaque index scores between pregnant and non-pregnant women
Measured: Day 1 (at the study visit one assessment per participant)
Gingival index
comparison of gingival index , scores between pregnant and non-pregnant women
Measured: Day 1 (at the study visit one assessment per participant)
Decayed , missing and filled teeth (DMFT index)
comparison of DMFT index scores between pregnant and non-pregnant women to assess dental carries experience
Measured: Day 1 (at the study visit one assessment per participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Induced GingivitisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kurdistan Higher Council of Medical Specialties
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vaheel Qasim Othman, Kurdistan Higher Council of Medical Specialties
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896694
- Sponsor's protocol ID
- 4454
- Other IDs
- self funding
- Acronym
- PREG_ORAL
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of participant confidentiality and privacy considerations. The study results may be shared through scientific publications without identifying individual participants.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Salivary Flow Rate, pH, Buffering Capacity, and Oral Health Status in Pregnant vs Non-Pregnant Women
- ClinicalTrials.gov ID
- NCT07896694
- Acronym / sponsor ID
- PREG_ORAL / 4454
- Conditions
- Plaque Induced Gingivitis
- Keywords
- pregnancy, oral health, saliva pH, plaque index
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kurdistan Higher Council of Medical SpecialtiesUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
This study compares saliva characteristics and oral health status between pregnant and non-pregnant women. It evaluates salivary pH, buffering capacity, stimulated and unstimulated saliva flow rates, and oral health indicators, including dental caries, plaque, and gingival health. The study aims to identify differences in saliva characteristics and oral health between the two groups and explore how these findings are associated with pregnancy. The results may help improve understanding of oral health needs during pregnancy and support better oral health education and preventive care for pregnant women. Participants undergo oral health examinations and saliva collection. No medication or treatment is being tested as part of this study.
Detailed description
Pregnancy is associated with physiological and hormonal changes that may be accompanied by changes in saliva characteristics and oral health. These changes may be associated with alterations in salivary pH, buffering capacity, and salivary flow, as well as differences in dental caries, plaque accumulation, and gingival health.
This study aims to compare saliva characteristics and oral health status between pregnant and non-pregnant women. The study evaluates salivary pH, buffering capacity, stimulated and unstimulated salivary flow rates, and oral health indicators. It also explores differences in these outcomes among pregnant women at different stages of pregnancy.
Participants undergo an oral health examination and saliva collection to assess the selected outcomes. The findings will provide information about the association between pregnancy, saliva characteristics, and oral health status.
The results may contribute to a better understanding of oral health needs during pregnancy and support the development of appropriate preventive dental care and oral health education strategies for pregnant women. The study is observational and does not involve testing a drug or providing an experimental treatment.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1: Pregnant women | – | – |
| group 1: Pregnant women group2: non-pregnant women | – | Other: saliva analysis and oral health Assessment, Other: Saliva assessment using the GC Saliva-Check Buffer kit to measure salivary pH and buffering capacity, alongside stimulated and unstimulated salivary flow rate measurements.group 1 Pregnant women participating in the study undergo an oral health examination and saliva collection to assess salivary pH, buffering capacity, stimulated and unstimulated salivary flow rates, and oral health status. No intervention is administered group 2 Non-pregnant women participating in the study undergo an oral health examination and saliva collection to assess salivary pH, buffering capacity, stimulated and unstimulated salivary flow rates, and oral health status. No intervention is administered. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consists of adult women aged 18 years and older, including pregnant and non-pregnant women. Pregnant participants are recruited from Erbil Maternity Hospital, while non-pregnant participants are recruited from Azadi Center. Eligible participants are included according to the study's inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- Healthy pregnant women at any trimester aged 18-40
- Healthy non-pregnant women in the same age group
- Women who are not using oral contraceptives.
- No history of radiation therapy to the head and neck region -
Key exclusion criteria (6 listed)
- Women with systemic diseases or salivary gland disorders.
- Women taking medications that may affect saliva composition.
- Smokers or individuals with poor oral hygiene.
- Women who consumed food, drinks, or tobacco within one hour before sample collection.
- Participants with oral mucosal diseases.
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 |
|---|---|---|
| saliva analysis and oral health AssessmentAssessment of salivary pH, buffering capacity, stimulated and unstimulated salivary flow rates, and oral health status through saliva collection and oral examination in pregnant and non-pregnant women. | Other | group 1: Pregnant women group2: non-pregnant women |
| Saliva assessment using the GC Saliva-Check Buffer kit to measure salivary pH and buffering capacity, alongside stimulated and unstimulated salivary flow rate measurements.Not applicable. This is an observational comparative cross-sectional study with no intervention. | Other | group 1: Pregnant women group2: non-pregnant women |
Primary outcome
Salivary pH
Time frame: Day 1 (at the study visit one assessment per participant)
Comparison of salivary pH between pregnant and non-pregnant women.
Saliva buffering capacity
Time frame: Day 1 (at the study visit one assessment per participant)
comparison of salivary buffering capacity scores between pregnant and non-pregnant women ,assessed using the GC saliva-check buffer kit
unstimulated salivary flow rate
Time frame: Day 1 (at the study visit one assessment per participant)
comparison of unstimulated salivary flow rate between pregnant and non-pregnant women, measured by passive saliva collection over 5 minutes
stimulated salivary flow rate
Time frame: Day 1 (at the study visit one assessment per participant)
comparison of stimulated salivary flow rates between pregnant and non-pregnant women following stimulation with paraffin wax and saliva collection over 5 minutes
3 secondary outcomes
Plaque index
Time frame: Day 1 (at the study visit one assessment per participant)
Gingival index
Time frame: Day 1 (at the study visit one assessment per participant)
Decayed , missing and filled teeth (DMFT index)
Time frame: Day 1 (at the study visit one assessment per participant)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of participant confidentiality and privacy considerations. The study results may be shared through scientific publications without identifying individual participants.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Induced Gingivitis, run by Kurdistan Higher Council of Medical Specialties at 1 site in Iraq.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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 Iraq. 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?
This study is still under way. Results are not available in the source record yet.
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?
Salivary pH (time frame: Day 1 (at the study visit one assessment per participant)). The study lists 4 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 27 Oct 2026.