NCT06109701

Brief Summary

Implants have become a popular and widely used treatment option for treating partial and total edentulism. As the number of implants placed increases, so does the incidence of peri-implant mucositis and peri-implantitis. Placing patients under SPT/maintenance care has been shown to prevent and treat such conditions. Despite SPT's importance in prevention and infection control, adherence to scheduled SPT visits have been unsatisfactory. Understanding the reasons for non-compliance can help both the clinician and research community to address them by improving patients experience to those visits thereby increasing compliance.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

September 6, 2023

Last Update Submit

January 31, 2024

Conditions

Peri-ImplantitisPeri-implant Mucositis

Keywords

Peri-implantitispreventionperi-implant mucositispain perception

Outcome Measures

Primary Outcomes (1)

  • Patient Pain/Discomfort (VAS) reported after decontamination during SPT.

    0 = no pain and 10 = extreme, unbearable pain

    immediately after the procedure

Secondary Outcomes (10)

  • Compliance to Supportive Periodontal Treatment (SPT) reported after decontamination during SPT.

    24 months

  • Changes in Full mouth plaque index (FMPI)

    24 months

  • Changes in Full mouth plaque index (FMBI)

    24 months

  • Changes in Periodontal probing depth (PPD)

    24 months

  • Changes in gingival recession (GR)

    24 months

  • +5 more secondary outcomes

Study Arms (2)

Control Group - Ultrassonic Devices

ACTIVE COMPARATOR

Supra and sub-gingival debridement with an ultrasonic device (DTE-D5, Woodpecker®, Guilin, China) with a plastic tip (Hu-Friedy®, Rockwell St, Chicago, IL, USA) and scaling with plastic curettes (Hu-Friedy®, Rockwell St, Chicago, IL, USA) around dental implants and a conventional metal tip for teeth will be used.

Procedure: Debridement with ultrasonic device and scaling with plastic curettes

Test Group - Erythritol based air-polishing powder

EXPERIMENTAL

Supra and sub-gingival debridement with an erythritol based air-polishing powder (Air-Flow, EMS, Nyon, CH) will be used during 5 seconds on each site (Schwarz et al., 2015).

Procedure: Debridement with erythritol based air-polishing powde

Interventions

Debridement with ultrasonic device and scaling with plastic curettesPROCEDURE

Supragingival and subgingival debridement

Also known as: Supportive periodontal / peri-implant treatment
Control Group - Ultrassonic Devices
Debridement with erythritol based air-polishing powdePROCEDURE

Supragingival and subgingival debridement

Also known as: Supportive periodontal / peri-implant treatment
Test Group - Erythritol based air-polishing powder

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Partially edentulous patients, rehabilitated with at least one dental implant in the maxilla or mandible with at least 3 years of function;
  • No implant mobility;
  • Treated periodontal disease;
  • Non-smoker or light smoking status in smokers (\<10 cigarettes/day).

You may not qualify if:

  • Patients with diagnosed fibromyalgia disorder or who are taking drugs that might influence the perception of pain (i.e., opioids, gabapentin) will be excluded from the study (Alcalde et al. 2017).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Universitaria de Odontologia

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Interventions

DebridementTooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Cristina V Vallès, Dentist

    Universitat Internacional de Catalunya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiago R Amaral, Dentist

CONTACT

+351916067069tamaral@uic.es

Cristina V Vallès, Dentist

CONTACT

cristinavallveg@uic.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

September 6, 2023

First Posted

October 31, 2023

Study Start

June 1, 2023

Primary Completion

December 31, 2024

Study Completion

June 1, 2025

Last Updated

February 2, 2024

Record last verified: 2024-01

Locations

ES(1)