Immediate Implants in the Aesthetic Zone

Not Applicable

Completed

• Conditions: Immediate Dental Implant

• Registration Number: NCT04343833
• Lead Sponsor: Universidad de Murcia

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

Study Timeline

• Study Start: 2017-10-02
• Primary Completion: 2020-01-16
• Status Verified: 2020-04
• Study Completion: 2020-04-04
• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-09
• Last Update Submitted: 2020-04-11
• Study First Posted: 2020-04-13
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bone level	After 12 months of definitive implant load	The bone level (BL) was determined by an intraoral digital radiograph taken parallel to the long axis of the implant.; The distance from the implant neck to the first contact between the bone and the implant was determined. It was measured in both sides, mesial and distal, and the mean between both values was established as the BL value.
PES/WES	After 12 months of definitive implant load	Pink Esthetic Score/White Esthetic Score \[PES/WES\] The parameters evaluated by this index are (1) mesial papilla, (2) distal papilla, (3) curvature of facial mucosa, (4) level of facial mucosa, and (5) root convexity/soft tissue color and texture. Each parameter range between 0 and 2. A maximum score of 10 can be obtained, considering acceptable from 6 The WES focuses specifically on the visible part of the restoration and in base on the following five parameters: (1) tooth form, (2) tooth volume/outline, (3) color (hue and value), (4) Surface texture, and (5) translucency. Each parameter is evaluated by comparison with the adjacent teeth, giving a value ranged from 0 to 2. A total score of 10 can be obtained, considering acceptable from 6

Trial Locations

Locations (1)

Medicine and Dentistry Faculty, Murcia University, Morales Meseguer Hospital; 🇪🇸 Murcia, Spain