Buccal and Palatal Bone Thickness and Marginal Bone Changes Implants (IBPTHPIBC)

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

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)

Study Overview

• Status: Completed
• Conditions: Bone Implant; Complications
• Intervention / Treatment: Procedure: implant insertion

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 Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Italy
  • CS
    • Cassano allo Ionio, CS, Italy, 87011
      • Hesire
  • VR
    • Verona, VR, Italy, 37045
      • Studio B

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Any patient presenting a single edentulism in the upper premolar area and requiring implant-prosthetic rehabilitation was eligible for this study. Furthermore, patients have to comply with the following inclusion and exclusion criteria.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
maxillary group; implant insertion	Procedure: implant insertion; bone level dental implant insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peri-implant bone changes in width buccal	measurement after implant site preparation with a caliper	three months after surgery
peri-implant bone changes in width palatal	measurement after implant site preparation with a caliper	three months after surgery
peri-implant bone changes in height buccal	measurement after implant insertion with a probe	three months after surgery
peri-implant bone changes in height palatal	measurement after implant insertion with a probe	three months after surgery

Collaborators and Investigators

• Sponsor: International Piezosurgery Academy
• Collaborators: University of Trieste; University of Campania "Luigi Vanvitelli"; University of Messina
• Investigators: Study Chair: Claudio Stacchi, Dr, Piezoelectric Surgery Academy

Publications and helpful links

General Publications

• Merheb J, Quirynen M, Teughels W. Critical buccal bone dimensions along implants. Periodontol 2000. 2014 Oct;66(1):97-105. doi: 10.1111/prd.12042. Review.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: November 20, 2022
• First Submitted That Met QC Criteria: November 20, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 20, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: implant; peri-implant bone remodeling; posterior maxilla; bone thickness
• Other Study ID Numbers: maxillary contraction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No