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Active, not recruitingNCT07896694PREG_ORALUpdated Oct 27, 2026

Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women

An observational study in Plaque Induced Gingivitis, sponsored by Kurdistan Higher Council of Medical Specialties. Active, not recruiting at 1 site in Iraq. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Kurdistan Higher Council of Medical Specialties · Observational

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years to 40 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Plaque Induced Gingivitis

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Keywords

  • pregnancy
  • oral health
  • saliva pH
  • plaque index
03

In context

Gingivitis

631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.

This study's enrollment of 200 is above the median of 93 across 116 observational studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Kurdistan Higher Council of Medical Specialties is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy pregnant women at any trimester aged 18-40
  2. Healthy non-pregnant women in the same age group
  3. Women who are not using oral .
  4. No history of radiation therapy to the head and neck region -

Exclusion criteria

Exclusion Criteria:

  1. Women with systemic diseases or salivary gland disorders.
  2. Women taking medications that may affect saliva composition.
  3. Smokers or individuals with poor oral hygiene.
  4. Women who consumed food, drinks, or tobacco within one hour before sample collection.
  5. Participants with oral mucosal diseases.
  6. Individuals wearing orthodontic or partial prosthetic appliances -
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • group 1: Pregnant women
  • 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.

    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.

Interventions

  • Othersaliva analysis and oral health Assessment

    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.

  • OtherSaliva 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.

06

What researchers measure

Primary outcomes

  1. Salivary pH

    Comparison of salivary pH between pregnant and non-pregnant women.

    Time frame: Day 1 (at the study visit one assessment per participant)

  2. Saliva buffering capacity

    comparison of salivary buffering capacity scores between pregnant and non-pregnant women ,assessed using the GC saliva-check buffer kit

    Time frame: Day 1 (at the study visit one assessment per participant)

  3. unstimulated salivary flow rate

    comparison of unstimulated salivary flow rate between pregnant and non-pregnant women, measured by passive saliva collection over 5 minutes

    Time frame: Day 1 (at the study visit one assessment per participant)

  4. 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

    Time frame: Day 1 (at the study visit one assessment per participant)

Secondary outcomes

  1. Plaque index

    Comparison of plaque index scores between pregnant and non-pregnant women

    Time frame: Day 1 (at the study visit one assessment per participant)

  2. Gingival index

    comparison of gingival index , scores between pregnant and non-pregnant women

    Time frame: Day 1 (at the study visit one assessment per participant)

  3. Decayed , missing and filled teeth (DMFT index)

    comparison of DMFT index scores between pregnant and non-pregnant women to assess dental carries experience

    Time frame: Day 1 (at the study visit one assessment per participant)

07

Study locations

1 site
  • Erbil Maternity Hospital
    Erbil, Iraq
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07896694
Lead sponsor
Kurdistan Higher Council of Medical Specialties
Responsible party
Vaheel Qasim Othman (Dentist and phD candidate in dental public health, Kurdistan Higher Council of Medical Specialties) — Principal investigator
First posted
Oct 27, 2026
Start date
Mar 1, 2026
Primary completion
Mar 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Oct 27, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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