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:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT03435757
Eligibility Criteria:
Inclusion Criteria:
* Patients with chronic periodontitis
* Presence of non- contained osseous defect
* Age 28 to 60 years (both males and females)
* Completed etiological periodontal therapy (oral hygiene instructions and scaling and root planing under local anaesthesia.
* At re-evaluation full mouth plaque score67 \< 1, full mouth bleeding score FMBS \<20%
* Non-smokers (Current and past smokers)
* Presence of ≥ 2mm of keratinized tissue to allow flap management
Tooth defect criteria:
* Probing pocket depth ≥ 5mm
* Clinical attachment loss ≥ 5mm
* Associated with a 1-wall, 2-wall or a combined 1-2 wall osseous defect ≥ 3mm deep located in the interproximal area of single- and multirooted teeth (assessed by transgingival probing and radiograph, further to be confirmed after flap elevation)
* Tooth mobility ≤ 1
* Concerned tooth and adjoining teeth to be vital and without symptoms or signs of endodontic involvement
* Tooth and adjoining teeth free of caries or inadequate restorations/ unrestorable tooth.
* Absence of non-working interferences.
* Interproximal intrabony defects not extending into the furcation area of molar teeth.
Exclusion Criteria:
* Medical conditions interfering with periodontal health or wound healing
* Systemic illness known to affect the periodontium or outcome of periodontal therapy.
* Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
* Patients allergic to medication (local anaesthetic, antibiotics, NSAID).
* Pregnant or lactating women.
* Fractured/perforated roots.
* Developing permanent tooth.
* History of recent periodontal treatment within 6 months prior to study.
* 3-wall intrabony defects
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
28 Years
Maximum Age:
60 Years
Study:
NCT03435757
Study Brief:
Protocol Section:
NCT03435757