Immediate Implants in the Aesthetic Zone

Immediate Dental Implant Clinical Trial

Official title:

Primary Stability and PES/WES Evaluation for Immediate Implants in the Aesthetic Zone: a Clinical Double-blind Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343833
• Other study ID #: 2076/20018
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: April 4, 2020

Study information

• Verified date: April 2020
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 4, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Immediate Dental Implant

Intervention

Procedure:
• Immediate dental implants
At the time of operation, the tooth was atraumatically extracted, and the implant was immediately placed following the surgical protocol recommended by the manufacturer. A temporary prosthesis was made without occlusal contact.

Locations

Country	Name	City	State
Spain	Medicine and Dentistry Faculty, Murcia University, Morales Meseguer Hospital	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone level	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.	After 12 months of definitive implant load
Primary	PES/WES	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	After 12 months of definitive implant load