Effect of EE/NETA With Scaling on Periodontium and hsCRP in PCOS Women With Gingivitis

NCT05129878 | Completed DMC

• 1 other identifier: RICHA PERIO
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 2

Brief Summary

As gingivitis is known to add to the systemic inflammatory burden and may consequently contribute to progression of PCOS and vice-versa, So, controlling local and systemic inflammatory burden by scaling g and medical treatment may have an effect in the management of PCOS women having gingivitis.There is no data as yet, comparing the impact of COCs along with scaling and COCs along with just oral hygiene instructions on the periodontal health of PCOS patients. Therefore, there is need to study the effect of combined oral contraceptives (ethinylestradiol/norethisterone acetate) along with scaling on periodontal status and high sensitivity C-Reactive Protein in polycystic ovary syndrome women having gingivitis

Conditions

Gingivitis; PCOS

Outcome Measures

Primary Outcomes (2)

• Bleeding on probing (BOP)

  BOP will recorded as 1 (present) if it occurred within 15 sec of probing and 0 (absent) if no bleeding occurred. It will be calculated in %. After adding all the scores, total score will be divided by the total no. of surfaces accessed and multiplied by 100. It will be designed as % sites with bleeding on probing.

  6 months

• Serum high sensitivity C reactive protein (hsCRP) levels

  Venous blood from the antecubital vein will be collected after applying a tourniquet in plain tubes without additive. Serum hsCRP levels will be assessed using a kit with high sensitivity methodology in an auto-analyzer according to the manufacturer's instructions. The test principle will be particle-enhanced immune-turbidimetric assay,in which human CRP agglutinates with the latex particles coated with monoclonal anti-CRP antibodies.

  6 months

Study Arms (3)

Test group 1

EXPERIMENTAL

patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive scaling and oral hygiene instructions (OHI)

Procedure: scaling and OHI

Test group 2

EXPERIMENTAL

patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions only

Procedure: oral Hygiene instructions

Control Group

ACTIVE COMPARATOR

Systemically Healthy (age and BMI matched) females with gingivitis will receive with OHI and scaling.

Procedure: Scaling and oral hygiene instruction

Interventions

scaling and OHI PROCEDURE

patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive scaling and oral hygiene instructions

Test group 1

oral Hygiene instructions PROCEDURE

patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions only

Also known as: Education and motivation

Test group 2

Scaling and oral hygiene instruction PROCEDURE

Systemically Healthy (age and BMI matched) females with gingivitis will receive with OHI and Scaling

Control Group

Eligibility Criteria

• Age: 15 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- For test groups
• females of reproductive age group (15-40 yrs)
• BMI (18.5 - 24.9)
• The diagnosis of PCOS according to Rotterdam criteria(37), when any two out of the following three abnormalities will be present:
• clinical (hirsutism, acne or acanthosis nigricans) and/or biochemical (raised testosterone) hyperandrogenism chronic anovulation (oligomenorrhoea or amenorrhea) polycystic ovaries on ultrasound (one or both ovaries demonstrate 12 or more follicles measuring 2 to 9 mm in diameter or the ovarian volume exceeds 10 cubic cm on pelvic ultrasound)
• presence of ≥20 natural teeth
• gingivitis by using the criteria laid down by World Workshop 2017
• For Test Group 2
• Participants will receive professional oral hygiene instructions during the trial and will be given cause related treatment after observation period of 6 months.
• Delaying treatment will not be considered unethical because of the low risk of disease progression over 6 months (41) and because these individuals will be monitored frequently and offered immediate (rescue) treatment if their disease progresses. Such cases will be excluded from the study. Periodontitis progression will be defined as an increase in CAL of 2 mm at any tooth site(42).
• Participants will be enrolled in the present study after obtaining written informed consent after explaining the details of the study design in their native language.

You may not qualify if:

• history of androgen-secreting tumors, congenital adrenal hyperplasia and thyroid dysfunction
• nephrotic syndrome, chronic renal failure, significant cardiovascular disease, established type 1 or type 2 diabetes mellitus, active cancer within the last past 5 yrs
• smokers and alcoholics
• history of systemic antibiotics or oral contraceptives usage within last 3 months
• periapical pathology or oral inflammatory conditions other than periodontitis.
• any periodontal treatment within 6 months prior to study
• incisor molar pattern/grade C periodontitis (2017 classification)

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (2)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

Shikha Tewari

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Tooth Exfoliation; Educational Status

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Study Officials

• RICHA VERMA

  Post Graduate Institute of Dental Sciences,ROHTAK,HARYANA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: November 22, 2021
• Study Start: January 1, 2022
• Primary Completion: November 20, 2022
• Study Completion: November 20, 2022
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

IN (2)