Buccal and Palatal Bone Thickness and Marginal Bone Changes Implants

Completed

• Conditions: Bone Implant; Complications
• Interventions: Procedure: implant insertion

• Registration Number: NCT05632172
• Lead Sponsor: International Piezosurgery Academy

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.

Study Timeline

• Study Start: 2021-01-15
• Primary Completion: 2021-07-15
• Study Completion: 2021-09-15
• Status Verified: 2022-11
• Study First Submitted: 2022-11-20
• Study First Submitted QC: 2022-11-20
• Last Update Submitted: 2022-11-20
• Study First Posted: 2022-11-30
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
maxillary group	implant insertion	implant insertion

Primary Outcome Measures

Name	Time	Method
peri-implant bone changes in width palatal	three months after surgery	measurement after implant site preparation with a caliper
peri-implant bone changes in height buccal	three months after surgery	measurement after implant insertion with a probe
peri-implant bone changes in height palatal	three months after surgery	measurement after implant insertion with a probe
peri-implant bone changes in width buccal	three months after surgery	measurement after implant site preparation with a caliper

Trial Locations

Locations (2)

Hesire; 🇮🇹 Cassano allo Ionio, CS, Italy

Studio B; 🇮🇹 Verona, VR, Italy