Comparative Aesthetic Analysis Between Titanium and Ceramic Implants

Dental Implants Clinical Trial

Official title:

Comparative Aesthetic Analysis Between Titanium and Ceramic Implants: A 12-month Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04707677
• Other study ID #: CI_RCT_US16
• Status: Completed
• Phase: N/A
• Start date: September 15, 2015
• Est. completion date: March 30, 2020

Study information

• Verified date: February 2021
• Source: University of Santiago de Compostela
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The study was a double-blind randomized controlled clinical trial (RCT), with a parallel design, comparing ceramic (test group) and titanium (control group) implants, for the replacement of a single-tooth in the anterior maxilla. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Dental Implants

Intervention

Device:
• Titanium and ceramic dental Implants
Two types of implant placement and follow-up to compare the esthetic, clinical and radiographic parameters between them.

Locations

Country	Name	City	State
Spain	Master Periodoncia	Santiago De Compostela

Sponsors (1)

Lead Sponsor	Collaborator
University of Santiago de Compostela

Country where clinical trial is conducted

Spain, 

Outcome

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