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Clinical Trials/NCT05632172
NCT05632172
Completed
Not Applicable

Influence of Buccal and Palatal Bone Thickness on Post-surgical Marginal Bone Changes Around Implants Placed in Posterior Maxilla

International Piezosurgery Academy2 sites in 1 country90 target enrollmentJanuary 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bone Implant; Complications
Sponsor
International Piezosurgery Academy
Enrollment
90
Locations
2
Primary Endpoint
peri-implant bone changes in width palatal
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The primary outcome of the study was the vertical variation of peri-implant buccal and palatal bone level from implant placement (T0) to uncovering stage (3 months later - T1)

Detailed Description

despite various recommendations, there is insufficient evidence to set a threshold for minimal buccal bone thickness necessary to ensure peri-implant marginal bone stability and optimal aesthetic outcomes. Therefore, the aim of the present multi-centre prospective study was to investigate the influence of buccal and palatal bone thickness at the time of implant placement on peri-implant bone remodeling during the submerged healing period, with a strict control of possible confounding factors.

Registry
clinicaltrials.gov
Start Date
January 15, 2021
End Date
September 15, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
International Piezosurgery Academy
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age \> 18 years;
  • no smokers;
  • no history of periodontal disease;
  • healed bone crest (at least six months after tooth extraction);
  • crestal bone height ≥8 mm;
  • crestal bone with a minimum bucco-palatal width of 6 mm with no concomitant or previous bone augmentation procedures.

Exclusion Criteria

  • absolute contraindications to implant surgery
  • immunological or genetic disorders;
  • uncontrolled diabetes (HBA1c \> 7.5%);
  • present or past treatment with anti resorptive drugs;
  • oncologic patients;
  • history of head or neck radiotherapy;
  • alcohol or drugs abuse;
  • final insertion torque \> 50 Ncm.

Outcomes

Primary Outcomes

peri-implant bone changes in width palatal

Time Frame: three months after surgery

measurement after implant site preparation with a caliper

peri-implant bone changes in height buccal

Time Frame: three months after surgery

measurement after implant insertion with a probe

peri-implant bone changes in height palatal

Time Frame: three months after surgery

measurement after implant insertion with a probe

peri-implant bone changes in width buccal

Time Frame: three months after surgery

measurement after implant site preparation with a caliper

Study Sites (2)

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