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Clinical Trials/NCT07401238
NCT07401238CompletedNot Applicable

Piezo-assisted Expansion of Narrow Ridges for Implant-supported Treatment of Intercalated Mono-edentulism: A Case Series Study

University of Trieste0 sites20 target enrollmentStarted: December 15, 2016Last updated:
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Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Primary Endpoint
postoperative surgical width
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

the goal of the study was the evaluation of the clinical and histological performance of delayed inserted implants in augmented sites with a shaped solid graft inserted in an originally narrow alveolar edentulous ridge.

Detailed Description

Purpose To assess the efficacy of a two-stage piezo-assisted split crest technique and delayed implant insertion. Computed tomography, radiological, clinical, and histologic evaluation.

Research design Multicenter case-series

Sample size 20 patients People involved in the protocol At least 25 enrolled patients (5 per center) counting drop-outs

Inclusion criteria

  1. Patients with single mandibular or maxillary intercalated edentulism (1 implant) who require implant rehabilitation with conventional loading
  2. The edentulous site width should be comprised between 3 and 5mm for the first 3mm of height
  3. Presence of visible spongious bone in CBCT cross-sections
  4. The edentulous site must present at least 4mm wide band of keratinized tissue
  5. Plaque index < 20%, Bleeding index < 25%
  6. Medical condition of the enrolled patients should be within ASA 2 score
  7. Only no smokers, light smokers (< 10 per day) or electronic smokers will be accepted

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 99 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •1. Patients with single mandibular or maxillary intercalated edentulism (1 implant) who require implant rehabilitation with conventional loading
  • •The edentulous site width should be comprised between 3 and 5mm for the first 3mm of height
  • •Presence of visible spongious bone in CBCT cross-sections
  • •The edentulous site must present at least 4mm wide band of keratinized tissue
  • •Plaque index < 20%, Bleeding index < 25%
  • •Medical condition of the enrolled patients should be within ASA 2 score
  • •Only no smokers, light smokers (< 10 per day) or electronic smokers will be accepted

Exclusion Criteria

  • •1. Head and neck RT in the previous 5 years
  • •Previous or actual antiresorptive therapy
  • •Chronic corticosteroid therapy
  • •Active periodontal disease
  • •Pregnancy or breastfeeding
  • •Abuse of alcohol or drugs
  • •Incapability of understanding the purposes of the study (e.g. mental deficit)

Arms & Interventions

narrow ridge

Experimental

width comprised between 3 and 5 mm

Intervention: Alveolar Ridge Reconstruction (Procedure)

Outcomes

Primary Outcomes

postoperative surgical width

Time Frame: 5 months

radiologically measured alveolar expansion

Secondary Outcomes

  • new bone formation(5 months later than surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

prof. Roberto Di Lenarda

prof

University of Trieste

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