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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT05758103
Eligibility Criteria:
Inclusion Criteria:
(i) dental implants placed for at least 12 months according to the All-on-4® concept;
(ii) removal of the dental prosthesis as part of the conventional implant maintenance protocol;
(iii) modified Bleeding Index19 score \>0 in at least one implant in the studied rehabilitation;
(iv) implants connected to the prosthesis by means of transepithelial abutments;
(v) if there were natural teeth in opposing arch, they were periodontally healthy or had been treated for periodontitis and were on periodontal support with residual pockets ≤5mm;
(vi) demonstrated previous compliance with oral hygiene appointments; (vii) read and signed the informed consent.
Exclusion Criteria:
(i) Peri-implantitis proven clinically (implant mobility, suppuration and/or pocket depth (PD) ≥5mm) and/or radiographically (bone remodeling greater than 2mm in the first year of function20 and mean marginal bone loss greater than 0.2mm for each subsequent year21 in the rehabilitated arch that was intended to be studied);
(ii) clinically active peri-implantitis (mobility, suppuration and/or PD ≥5mm) in the opposing arch to the one intended to be studied;
(iii) presence of an extra-maxillary/zygomatic implant in the rehabilitated arch that was intended to be studied;
(iv) current probiotic supplementation;
(v) diabetes mellitus not controlled by medication;
(vi) current use of oral hygiene products containing chlorohexidine or essential oils;
(vii) special needs individuals who depended on others for their oral hygiene and medication uptake.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05758103
Study Brief:
Protocol Section:
NCT05758103