Comparative Aesthetic Analysis Between Titanium and Ceramic Implants
NCT ID: NCT04707677
Last Updated: 2021-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2015-09-15
2020-03-30
Brief Summary
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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.
Detailed Description
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All patients were randomized and assigned to each of the study groups through a computer-generated randomization.
Surgical and restorative procedures In the test group, a Tissue Level Ceramic monotype implant was placed (Straumann PURE Ceramic implants®; Institut Straumann, Basel, Switzerland) and in the control group a Tissue Level SLA Titanium implant (Straumann Standard Plus Narrow Neck CrossFit®; Institut Straumann, Basel, Switzerland). The length of the implants was 8, 10 and 12 mm.
The primary outcome was the Implant Crown Aesthetic Index (ICAI). It consists of nine sections: mesiodistal dimension of the crown, position of the incisal edge of the crown, labial convexity of the crown, color and translucency of the crown, crown surface, position of the gingival margin of the peri-implant mucosa, position of the interdental papilla, contour of the vestibular mucosa and 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CONTROL GROUP
Implant surgery placement. Tissue Level SLA Titanium implant (Straumann Standard Plus Narrow Neck CrossFit®; Institut Straumann, Basel, Switzerland). The implant had a diameter of 3.3 mm and a polished neck of 1.8 mm. The length of the implants was 8, 10 and 12 mm and was chosen according to the patient's anatomy.
Titanium and ceramic dental Implants
Two types of implant placement and follow-up to compare the esthetic, clinical and radiographic parameters between them.
TEST GROUP
Implant surgery placement. Tissue Level Ceramic monotype implant was placed (Straumann PURE Ceramic implants®; Institut Straumann, Basel, Switzerland). The implant had a diameter of 3.3 mm and a polished neck of 1.8 mm. The length of the implants was 8, 10 and 12 mm and was chosen according to the patient's anatomy.
Titanium and ceramic dental Implants
Two types of implant placement and follow-up to compare the esthetic, clinical and radiographic parameters between them.
Interventions
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Titanium and ceramic dental Implants
Two types of implant placement and follow-up to compare the esthetic, clinical and radiographic parameters between them.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy, or lactating women.
* Active periodontal disease
* Smoking \>10 cig/day
18 Years
ALL
Yes
Sponsors
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University of Santiago de Compostela
OTHER
Responsible Party
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Juan Blanco Carrión
Doctorate in Dentistry
Principal Investigators
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Juan Blanco
Role: STUDY_DIRECTOR
University of Santiago de Compostela
Locations
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Master Periodoncia
Santiago de Compostela, , Spain
Countries
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Other Identifiers
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CI_RCT_US16
Identifier Type: -
Identifier Source: org_study_id