NCT05670340

Brief Summary

In this clinical trial the effect of the implant-abutment morphology (platform-switched vs platform matched) will be assessed in both soft tissue (soft tissue thickness) and hard tissue (marginal bone loss) outcomes. Several clinical predictors (initial implant position level, gingival biotype, abutment height and prosthetic emergence profile) will also be taken into account as modulating factors of the clinical outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

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 22, 2020

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

3.3 years

First QC Date

November 29, 2022

Last Update Submit

May 14, 2024

Conditions

Dental ImplantSoft TissuePartial-edentulismBone Loss

Keywords

dental implantmarginal bone lossperi-implant soft tissueISQ

Outcome Measures

Primary Outcomes (3)

  • Change in the Peri-implant Marginal Bone level

    The implant-bone level is assesssed radiographicly

    At baseline (reference), in comparison with 3, 6 and 12 months

  • Change in the Implant stablity quotient

    The ISQ is assesssed by Osstell

    At baseline (reference), and in comparison with the 3 months follow-up

  • Change in the Gingival Thickness

    The gingival thickness will be assessed by measuring the keratinized region around implants with a periodontal probe and a thickness caliper

    At baseline (reference) and in comparison with the 3, 6 and 12 months follow-up

Study Arms (2)

Swithed-platform

EXPERIMENTAL

In this group the implants will be rehabilitated with a narrower emergence profile for the prosthetic rehabilitation.

Device: Switched Prosthetic Profile

Matched-platform

ACTIVE COMPARATOR

This the conventional approach in wich the prosthetic rehabilitation is matched with the implant-platform dimensions

Device: Matched Prosthetic Profile

Interventions

Switched Prosthetic ProfileDEVICE

The implant will be rehabilitated with a switched emergence profile

Swithed-platform
Matched Prosthetic ProfileDEVICE

The implant will be rehabilitated with a matched emergence profile

Matched-platform

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of legal age (\>18 years).
  • With rehabilitation needs with 1 maxillary or mandibular implant in mature bone (more than 4 months after tooth extraction) in the posterior sector (premolars and molars).
  • With good hygiene (plaque and gingival index ≤ 25%).

You may not qualify if:

  • Medical conditions that contraindicated implant surgery.
  • Patients with immunological alterations, pregnant and lactating.
  • Heavy smokers \> 20 cigarettes/day,
  • Requiring bone augmentations or of soft tissues.
  • Patients whose anatomy prevented the correct three-dimensional placement of the implant to perform prosthetically guided screw-retained restorations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Javier Montero

Salamanca, 37007, Spain

Location

Related Publications (1)

  • Quispe-Lopez N, Guadilla Y, Gomez-Polo C, Lopez-Valverde N, Flores-Fraile J, Montero J. The influence of implant depth, abutment height and mucosal phenotype on peri-implant bone levels: A 2-year clinical trial. J Dent. 2024 Sep;148:105264. doi: 10.1016/j.jdent.2024.105264. Epub 2024 Jul 23.

    PMID: 39053878DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
only the care provider knows the group asignement
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The implant abutment height could be short (\<2mm) or long (\>2mm)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor in Prosthodontics

Study Record Dates

First Submitted

November 29, 2022

First Posted

January 4, 2023

Study Start

January 22, 2020

Primary Completion

May 20, 2023

Study Completion

February 1, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)