Comparative Aesthetic Analysis Between Titanium and Ceramic Implants

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.

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Key information

Conditions

Dental Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Master Periodoncia

Santiago de Compostela, 15782, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Titanium and ceramic dental Implants

Device

Two types of implant placement and follow-up to compare the esthetic, clinical and radiographic parameters between them.

Primary outcomes

The primary outcome was the Implant Crown Aesthetic Index (ICAI).

Time frame: 36 months

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).

Sponsors and collaborators

Lead sponsor

University of Santiago de Compostela

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2020
First posted: Jan 13, 2021
Registry last updated: Dec 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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