Clinical trial NCT04343833: Immediate Implants in the Aesthetic Zone
Official title: Primary Stability and PES/WES Evaluation for Immediate Implants in the Aesthetic Zone: a Clinical Double-blind Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immediate Dental Implant
Keywords: Dental esthetics
Primary stability
Single-tooth restoration
Osseointegration.
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 20 patients, distributed in two groups with ten patient each (experimental and control) were included in this study. All patients signed a double informed consent, one for implant placement and one for their participation in the study. The study follows the Declaration of Helsinki recommendations. The Ethics Committee of the University of Murcia approved the study protocol with ID: 2076/2018.
Primary purpose: TREATMENT

Brief summary: The use of immediate implants in the aesthetic area is a technique widely used in modern implantology. The characteristics of the patient, the implant, and the surgical procedure used may influence the final results. The aim was to assess whether the implant design affects primary (PS) and secondary stability (SS), bone level (BL), and PES/WES evaluation.

Detailed description: 20 implants with two different designs (n=10) were immediately placed in the upper anterior maxilla with no grafting material. ISQ, BL, and PES/WES were evaluated. Results will analyze with the Wilcoxon-Mann-Whitney test (p\<0.05).

The random distribution is made prior to assignment following the internet prgram https://www.random.org

Eligibility criteria: Inclusion Criteria:

* Patients who presented aa vertical fracture in an upper incisor that can not be treated conservatively and ended in the extraction, and the treatment needed is a unitary implant.
* Good systemic health status (ASA I or II).
* Oral hygiene index of \< 2 (Löe and Silness).
* A minimum of 2 mm of attached mucosa.
* A minimum of 8 mm of vertical bone.
* A minimum of 7 mm of bucco-lingual bone.

Exclusion Criteria:

* Traumatic or complicated incisor extraction.
* Pregnant or women in the lactation period.
* Use of any medication that contraindicates implant treatment.
* A history of alcohol or drug abuse.
* A requirement for guided bone regeneration.
* A requirement for tissue graft augmentation.
* Failure to comply with the study protocol.

Primary outcomes:
measure: Bone level
timeFrame: After 12 months of definitive implant load
measure: PES/WES
timeFrame: After 12 months of definitive implant load
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Medicine and Dentistry Faculty, Murcia University, Morales Meseguer Hospital
Study officials:
References:
citation: Sanchez-Perez A, Nicolas-Silvente AI, Sanchez-Matas C, Molina-Garcia S, Navarro-Cuellar C, Romanos GE. Primary stability and PES/WES evaluation for immediate implants in the aesthetic zone: a pilot clinical double-blind randomized study. Sci Rep. 2021 Oct 8;11(1):20024. doi: 10.1038/s41598-021-99218-8.