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 @ 1:48 PM
Ignite Modification Date:
2025-12-24 @ 1:48 PM
NCT ID:
NCT01229995
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria:
General:
1. Age \> 21 years
2. Absence of relevant medical conditions
3. Absence of periodontal diseases
4. The opposing dentition must be natural teeth or fixed (not removable) restorations on teeth or implants.
5. Availability for 5-year follow-up
Local:
1. One missing tooth in the esthetic zone. An esthetic area is defined as any area that is visible in the patient's full smile. \[3rd ITI consensus conference 2004\]
2. Presence of two intact adjacent teeth which are either non-restored or with minor restorations (small composite restorations)
3. Adequate native bone to achieve primary stability
4. Adequate band of keratinized mucosa (at least 2mm)
5. Full Mouth Plaque Scores (FMPS) and Full Mouth Bleeding Scores (FMBS) \< 25 %
Exclusion Criteria:
Exclusion criteria
General:
1. Heavy smokers (more than 10 cigarettes/day)
2. Presence of conditions requiring chronic prophylactic use of antibiotics
3. Medical conditions requiring prolonged use of steroids.
4. History of radiation therapy to the head or neck or history of chemotherapy.
5. Physical handicaps that would interfere with the ability to perform adequate oral hygiene.
6. Patients with inadequate oral hygiene.
Local:
1\. Adjacent implant 2. Presence of periapical radiolucencies at the adjacent teeth 3. Missing adjacent teeth 4. Local inflammation, including untreated periodontitis. 5. Persistent intraoral infections. 6. Untreated mucosal diseases.
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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01229995
Study Brief:
Protocol Section:
NCT01229995