NCT03077880

Brief Summary

The aim of this observational study is the evaluation of marginal bone remodeling after surgical implant placement, correlating the gingival thickness with the bone resorption rate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

January 25, 2017

Last Update Submit

March 18, 2019

Conditions

Alveolar Bone Loss

Keywords

implant insertionbone resorptionsoft tissue

Outcome Measures

Primary Outcomes (1)

  • peri-implant bone resorption

    radiological assessment of change in the peri-implant bone crest

    from baseline to twelve months

Study Arms (2)

thin soft tissue

full thickness thin mucosal soft tissue at the periodontal probe measured intra-operatory measurement during implant placement

Procedure: intra-operatory measurement during implant placement

thick soft tissue

full thickness thick mucosal soft tissue at the periodontal probe measured intra-operatory measurement during implant placement

Procedure: intra-operatory measurement during implant placement

Interventions

intra-operatory measurement during implant placementPROCEDURE

mucoperiosteal flap, soft tissue thickness measurement, implant insertion

thick soft tissuethin soft tissue

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients referred to the centers

You may qualify if:

  • indications for intervention of implant placement in posterior mandible (premolar / molar region) based on a careful diagnosis and treatment plan;
  • presence of a residual osseous crest with a minimum of 7 mm surgical height, and thickness of at least 6 mm at the level of the programmed implant site;
  • the bone crest must be healed (at least 6 months after the loss / extraction of the element corresponding tooth);
  • absence of regenerated bone;
  • plaque index of less than 25% and bleeding index lower than 20%;
  • bucco-lingual width of the attached gingiva ≥ 4 mm;
  • insertion torque plant inserito≥35 N / cm;
  • patient age\> 18 years;
  • patients should be able to examine and understand the study protocol;
  • informed consent.

You may not qualify if:

  • acute myocardial infarction in the last two months;
  • blood coagulation disorders not compensated;
  • uncontrolled diabetes (HbA1c\> 7.5%);
  • radiation therapy of the district head / neck in the last 24 months;
  • immunocompromised patients (HIV infection or chemotherapy) within the last 5 years);
  • present or past treatment with intravenous bisphosphonates;
  • psychological or psychiatric diseases;
  • alcohol or drug abuse;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piezosurgery Academy

Parma, 43100, Italy

Location

Related Publications (1)

  • Sicilia A, Quirynen M, Fontolliet A, Francisco H, Friedman A, Linkevicius T, Lutz R, Meijer HJ, Rompen E, Rotundo R, Schwarz F, Simion M, Teughels W, Wennerberg A, Zuhr O. Long-term stability of peri-implant tissues after bone or soft tissue augmentation. Effect of zirconia or titanium abutments on peri-implant soft tissues. Summary and consensus statements. The 4th EAO Consensus Conference 2015. Clin Oral Implants Res. 2015 Sep;26 Suppl 11:148-52. doi: 10.1111/clr.12676.

    PMID: 26385628BACKGROUND

MeSH Terms

Conditions

Alveolar Bone LossBone Resorption

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Claudio Stacchi, Dr.

    Piezosurgery Academy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of Piezosurgery Academy

Study Record Dates

First Submitted

January 25, 2017

First Posted

March 13, 2017

Study Start

January 15, 2017

Primary Completion

July 15, 2018

Study Completion

September 15, 2018

Last Updated

March 20, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)