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Does Periodontal treatment prevent the occurrence of Preeclampsia and Still Birth in Pregnant women?

Does periodontal treatment affect the incidence of Preeclampsia and Still Birth in pregnant women. A single blinded, parallel arm, Randomized Controlled Trial.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001543279
Enrollment
100
Registered
2018-09-14
Start date
2018-09-18
Completion date
2018-12-04
Last updated
2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Periodontal disease is an inflammatory condition of the supporting tissues of the teeth that may affect the gum tissues involving periodontal ligament, cementum and might involving the bone. Several studies have suggested an association between the periodontal disease and pregnancy complications which can lead to the adverse pregnancy outcomes, such as Still birth, Preeclampsia, preterm delivery and low fetal birth weight, jeopardizing the lives of both the mother and the fetus. To determine if periodontal therapy works to reduce these adverse pregnancy outcomes, high quality randomized controlled trials are required. In this study we will try to assess the impact of prophylactic periodontal treatment in preventing the occurrence of preeclampsia and still birth.

Interventions

There will be two groups of pregnant females,a total of 100 participants, who fulfill the inclusion criteria. The 'experimental' group (n = 50) will first be provided with oral health education. This would include detailed instructions on how and when to brush their teeth. The instructions would be given orally with tooth brushing demonstration provided on a dental teeth model. Thereafter, the participants of the 'experimental' group will be receiving the periodontal treatment including oral hyg

There will be two groups of pregnant females,a total of 100 participants, who fulfill the inclusion criteria. The 'experimental' group (n = 50) will first be provided with oral health education. This would include detailed instructions on how and when to brush their teeth. The instructions would be given orally with tooth brushing demonstration provided on a dental teeth model. Thereafter, the participants of the 'experimental' group will be receiving the periodontal treatment including oral hygiene instructions and a non surgical scaling and polishing of the teeth,with the help of ultrasonic scaler tips and ultrasonic brushes respectively. As an incentive, the participants of the 'experimental group' will also be provided with a free tooth brush and a toothpaste. Once the treatment is provided, a dental checkup will be performed after 12 weeks of the treatment to evaluate the periodontal health status of the patients. The dental checkup would include an assessment of the periodontal status of the patient using the British Periodontal Examination (BPE) index. This is a validated and reliable instrument for the purpose of measuring the periodontal status of individuals.The Prophylactic treatment will be provided one time initially but if the patient requires further treatment at the followup,it must be provided. Other than periodontal treatment, the participants of both groups would be provided with necessary oral health care e.g restorations, endodontic treatment, if required, and this being assessed through complete oral examination, DMFT charting that will carried out at the initial assessment of the patient. The treatment will be provided by the house officers,in the supervision of trained dentists in the periodontology department of Fauji Foundation Hospital, Rawalpindi. a dental checkup will be performed after 12 weeks of the treatment to evaluate the periodontal health status of the patients. The dental checkup would include an assessment of the periodontal status of the patient using the British Periodontal Examination (BPE) index. This is a validated and reliable instrument for the purpose of measuring the periodontal status of individuals.The Prophylactic treatment will be provided one time initially but if the patient requires further treatment at the followup,it must be provided. Other than periodontal treatment, the participants of both groups would be provided with necessary oral health care e.g restorations, endodontic treatment, if required, and this being assessed through complete oral examination, DMFT charting that will carried out at the initial assessment of the patient. The treatment will be provided by the house officers,in the supervision of trained dentists in the periodontology department of Fauji Foundation Hospital, Rawalpindi. At the 12 weeks checkup, the blood pressure of the patient would be measured using a mercurial sphygmomanometer and urine analysis will be done to check for proteinurea. This analysis will be done to assess the preeclampsia status of the patients.

Sponsors

Riphah International University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

Maternal Age(18-45 years) Gestational Age (3rd trimester of pregnancy) Normal BLood pressure Range (120/80 mmHg) No Periodontal therapy within 6 months before pregnancy

Exclusion criteria

Gingivitis,Periodontitis History of smoking Body Mass Index (BMI),is out of range (BMI is 30 or Higher) History of Hypertensive disorders History of previous premature births or any of the adverse pregnancy outcomes Metabolic Disorders(Diabetes,Renal disorders etc)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026