Buccal and Palatal Bone Thickness and Marginal Bone Changes Implants

NCT05632172 | Completed

• 1 other identifier: maxillary contraction
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

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)

Conditions

Bone Implant; Complications

Keywords

implant; peri-implant bone remodeling; posterior maxilla; bone thickness

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

maxillary group

implant insertion

Procedure: implant insertion

Interventions

implant insertion PROCEDURE

bone level dental implant insertion

maxillary group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Piezosurgery Academy: lead
• University of Trieste: collaborator
• University of Messina: collaborator
• University of Campania Luigi Vanvitelli: collaborator

Study Sites (2)

Hesire

Cassano Allo Ionio, CS, 87011, Italy

Location

Studio B

Verona, VR, 37045, Italy

Location

Related Publications (2)

• 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.

  PMID: 25123763 RESULT

• Cicciu M, Pratella U, Fiorillo L, Bernardello F, Perillo F, Rapani A, Stacchi C, Lombardi T. Influence of buccal and palatal bone thickness on post-surgical marginal bone changes around implants placed in posterior maxilla: a multi-centre prospective study. BMC Oral Health. 2023 May 22;23(1):309. doi: 10.1186/s12903-023-02991-3.

  PMID: 37217911 DERIVED

Study Officials

• Claudio Stacchi, Dr

  Piezoelectric Surgery Academy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: November 30, 2022
• Study Start: January 15, 2021
• Primary Completion: July 15, 2021
• Study Completion: September 15, 2021
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)