Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT02627534
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of type 2 DM for ≥5 years
* DM treatment with oral hypoglycemic agents or insulin supplementation and diet
* glycated hemoglobin (HbA1c) levels from 6.5% to 11%
* at least 15 teeth (excluding third molars and teeth indicated for extraction)
* moderate to severe generalized chronic periodontitis (Armitage, 1999)
* agree and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the study (Resolution number 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO179/93).
Exclusion Criteria:
* medical conditions that required prophylactic antimicrobial coverage
* SRP in the previous 6 months
* antimicrobial therapies in the previous 6 months
* anti-inflammatory therapies in the previous 6 months
* systemic conditions, other than DM, that could affect the progression of chronic periodontitis
* current use of medication that could interfere with periodontal response to treatment
* pregnancy or lactation
* smoking
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT02627534
Study Brief:
Protocol Section:
NCT02627534