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Immediate Implants in the Aesthetic Zone

Not Applicable
Completed
Conditions
Immediate Dental Implant
Interventions
Procedure: Immediate dental implants
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

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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control with Standard dental implantImmediate dental implantsPatients were treated with implants Inhex Ticare Standard (Mozo Grau, Ticare, Valladolid, Spain). The implants presented a surface treated with Reabsorbable Blast Media (RBM), conical macro-design with non-aggressive threads, internal connection, and platform switching. On the implant shoulder, the beveled design of the platform was characterized by a rounded shape of 45º.
Test with the new implant designImmediate dental implantsPatients were treated with Implants Inhex Quattro Ticare (Mozo Grau, Ticare, Valladolid, Spain). The implants also presented a surface treated with RBM, conical macro-design with expanded micro threads, internal connection, and platform switching.On the implant shoulder, the beveled design of the platform was characterized by a rounded shape of 45º.
Primary Outcome Measures
NameTimeMethod
Bone levelAfter 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/WESAfter 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Medicine and Dentistry Faculty, Murcia University, Morales Meseguer Hospital

🇪🇸

Murcia, Spain

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