Clinical trial NCT04707677: Comparative Aesthetic Analysis Between Titanium and Ceramic Implants
Official title: Comparative Aesthetic Analysis Between Titanium and Ceramic Implants: A 12-month Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two study groups, test (titanium implants) and control (ceramic implants)
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome was the Implant Crown Aesthetic Index (ICAI).
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Master Periodoncia
Study officials:
affiliation: University of Santiago de Compostela
name: Juan Blanco
role: STUDY_DIRECTOR
References: