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Completed

NCT Number: NCT04343833

Immediate Implants in the Aesthetic Zone

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.

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Key information

Conditions

Immediate Dental Implant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medicine and Dentistry Faculty, Murcia University, Morales Meseguer Hospital

Murcia, 30008, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Immediate dental implants

Procedure

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.

Other names: Fresh extraction sockets

Primary outcomes

  1. Bone level

    Time frame: 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.

  2. PES/WES

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2020
Registry last updated
Apr 14, 2020

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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