Lnfluence of the Prosthetic Emergence Profile on the Prevalence of Peri-implant Diseases

NCT05592314 | Recruiting

• 1 other identifier: PER-ECL-2020-09a
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Objectives:
2. 2.Material and methods:
3. 3.Number of patients to be treated: 120
4. 4.Number of visits per patient: 1
5. 5.Brief description of the different techniques used in the study, authorized and validated in the literature (3-5 lines).
6. 6.Benefits and harms of participating in the study for the patient
7. 7.Alternative treatment in case the patient does not wish to participate in the clinical study
8. 8.Treatment to be carried out in the event that complications arise in the patient, once the clinical study has begun
9. 9.Material needed to carry out the study (
10. 10.Evaluation of experimental and statistical results (3 lines) -

Conditions

Peri-Implantitis

Keywords

Dental Implant; Dental prosthesis; Implant-supported; Prevalence; Risk factors

Outcome Measures

Primary Outcomes (1)

• Evaluate the influence of excessively contour or overcontoured restorations

  Defined as those that present an emergency profile with a marked emergency angle and/or convex profile evaluated by intraoral scanning, in the risk of suffering from peri-implant diseases

  February 2021 - may 2023

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient presents at least one implant-supported restoration in the posterior region (molars and premolars), placed at the university between 2010 and 2017.

You may qualify if:

• Patients aged 18-80 years,
• Implant properly positioned (≥ 2 mm from the buccal plate and \>1 mm from the lingual plate or in the ideal occlusal plane horizontally, 5 to 2 mm from the adjacent CEJ or from 2 mm below the residual ridge to crestal position (0 mm) apico-coronally and with an angulation of 70 to 90 degrees from the adjacent tooth long axis or from the ridge parallelism) (21),
• Implant loading for more than 3 years,
• Partial or total edentulism being restored with dental implants in the molar and premolar region with single or partial restorations.
• Patients who have not taken any antibiotic and regular NSAIDs in the last 2 months prior to the clinical examination,

You may not qualify if:

• Uncontrolled systemic diseases (i.e., diabetes mellitus)
• Pregnancy or lactation patients,
• Smokers of ≥10 cig/day.
• Zygomatic or pterygoid implants,
• Removable prostheses and cement-retained implant prostheses,
• Patients who have undergone non-surgical peri-implant treatment with prosthesis modifications, peri-implantitis surgical treatment or soft tissue augmentation procedures at the implant site.
• Intake of medications known to modify bone metabolism (i.e., hyperparathyroidism, osteoporosis, and vitamin D deficiency),
• Uncontrolled or active periodontal disease that required treatment.

Sponsors & Collaborators

• Ramón Pons Calabuig: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Leire Izaskun, DDS

CONTACT

628362896; leiizas@uic.es

Ramón Pons, DDS, MSc

CONTACT

619688364; ramonponsdds@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinica Professor

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 24, 2022
• Study Start: May 5, 2021
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)