Comparative Aesthetic Analysis Between Titanium and Ceramic Implants

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Implants
• Intervention / Treatment: Device: Titanium and ceramic dental Implants

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Santiago De Compostela, Spain, 15782
    • Master Periodoncia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Titanium and ceramic dental Implants; Two types of implant placement and follow-up to compare the esthetic, clinical and radiographic parameters between them.
Experimental: 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.	Device: Titanium and ceramic dental Implants; Two types of implant placement and follow-up to compare the esthetic, clinical and radiographic parameters between them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Santiago de Compostela
• Investigators: Study Director: Juan Blanco, University of Santiago de Compostela

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2015
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: January 10, 2021
• First Submitted That Met QC Criteria: January 10, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): December 27, 2021
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CI_RCT_US16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No