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:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT06168500
Eligibility Criteria:
Inclusion Criteria:
Patients:
* 18 years old
* Healthy periodontal status (absence of generalized probing pocket depth (PPD) \<4mm)
* Oral hygiene levels (FMPS \<20 and FMBS \<20)
Site:
* Ridge width of \>5mm and \<6.5mm and minimum bone height of 10mm prior evaluation on a CBCT scan
* Presence of antagonistic natural tooth or fixed prosthetic restoration
* Presence of adjacent teeth
* One maxillary or mandibular premolars
* Minimum of 3mm of keratinized tissue over the bone crest (20)
* Bone regeneration within the limits of the prosthetic restoration.
Implants:
* Unitary prosthesis
* Screwed retained restorations
Exclusion Criteria:
Patients
* Presence of active chronic or aggressive periodontal disease
* Presence of systemic disease which contraindicate surgery (patients with an ASA ≥ 3)
* Drugs or medications which may alter the results (chronic intake of analgesic medication)
* Smokers (\>10cig/day)
* Pregnant women
* History of head and neck radiotherapy.
Site
* Anterior area (from 1.3 to 2.3 and from 3.3 to 4.3) and molar area
* Previous guided bone regeneration
* Location where there is not sufficient restorative space (mesio-distally \<8mm for every restoration unit and \<5mm from the bone crest to the antagonist)
* Implant dehiscence of more than 2/3 of the implant.
Implant
* Implants which cannot be restored with a screwed restoration
* Implants which doesn't reach a manual implant stability
* implants which after placement doesn't reach a favourable position according to the restoration.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06168500
Study Brief:
Protocol Section:
NCT06168500