Dental Implants Clinical Trial
Official title:
Comparative Aesthetic Analysis Between Titanium and Ceramic Implants: A 12-month Randomized Clinical Trial.
Verified date | February 2021 |
Source | University of Santiago de Compostela |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objective: The aim of this randomized clinical trial was to compare ceramic and titanium implants with respect to the esthetic and clinical parameters, and patient reported outcome measures (PROMs). Material and methods: Thirty patients received thirty implants (8-12 mm in length, 3.3 mm diameter and a tissue level design) to replace the absence of a single tooth in the anterior maxilla. Patients were randomly allocated to receive a ceramic or a titanium implant. Esthetic and clinical parameters and PROMs were evaluated 18 months after surgery.
Status | Completed |
Enrollment | 30 |
Est. completion date | March 30, 2020 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Periodontal and systemically healthy patients > 18 years of age, with good plaque control (< 25%). - Patients with a missing tooth in the anterior maxilla (from 13 to 23) with the presence of adjacent natural dentition mesially and distally (single gap). A minimum of 4 months of healing after tooth extraction was required before implant insertion. - Presence of = 2mm of keratinized tissue. - Simultaneous bone regeneration was allowed during surgery. Exclusion Criteria: - Intake any medication or presence of any systemic disease that could affect bone metabolism. - Pregnancy, or lactating women. - Active periodontal disease - Smoking >10 cig/day |
Country | Name | City | State |
---|---|---|---|
Spain | Master Periodoncia | Santiago De Compostela |
Lead Sponsor | Collaborator |
---|---|
University of Santiago de Compostela |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome was the Implant Crown Aesthetic Index (ICAI). | It consists of nine sections: (i) mesiodistal dimension of the crown, (ii) position of the incisal edge of the crown, (iii) labial convexity of the crown, (iv) color and translucency of the crown, (v) crown surface, (vi) position of the gingival margin of the peri-implant mucosa, (vii) position of the interdental papilla, (viii) contour of the vestibular mucosa and (ix) color and surface of the vestibular mucosa. These sections were compared with the adjacent and contralateral tooth as a reference and assigned the following score: 0, excellent; 1 or 2 satisfactory; 3 or 4 moderate; 5 or more bad (Meijer et al., 2005). | 36 months |
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