NCT07837947

Brief Summary

Supportive periodontal therapy (SPT) is essential for maintaining periodontal stability and preventing disease recurrence in patients who have been successfully treated for periodontitis. However, long-term effectiveness depends on regular attendance at maintenance visits, and negative experiences associated with periodontal instrumentation, such as pain or discomfort, may affect patient acceptance and adherence to the maintenance program. The aim of this randomized clinical trial is to evaluate whether supportive periodontal therapy performed using an air-polishing device with low-abrasive trehalose powder reduces patient-perceived pain and improves the clinical experience compared with conventional biofilm removal using ultrasonic instrumentation. The study will also assess whether the use of air polishing is associated with better adherence to the periodontal maintenance program while maintaining comparable periodontal clinical outcomes. Forty periodontally stabilized adult patients enrolled in the supportive periodontal therapy program of the Master's Degree in Periodontology and Peri-implantology at the University of Barcelona will be randomly allocated in a 1:1 ratio to one of two parallel treatment groups. The control group will receive conventional supportive periodontal therapy using ultrasonic instrumentation, while the experimental group will receive supportive periodontal therapy using an air-polishing device with low-abrasive trehalose powder. Participants will be followed for 24 months. The primary outcome will be patient-perceived pain associated with supportive periodontal therapy, assessed using a visual analogue scale (VAS). Secondary outcomes will include treatment duration, adherence to scheduled maintenance visits, patient experience and acceptance of treatment, and periodontal clinical parameters. Periodontal status will be monitored throughout follow-up by assessing probing pocket depth, clinical attachment level, bleeding on probing, and plaque index. This study aims to determine whether air polishing with trehalose powder can provide a more comfortable and patient-centered approach to supportive periodontal therapy without compromising periodontal clinical outcomes, and whether an improved treatment experience may contribute to better long-term adherence to periodontal maintenance.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026May 2027

First Submitted

Initial submission to the registry

September 12, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

Same day

First QC Date

September 12, 2026

Last Update Submit

September 20, 2026

Conditions

Keywords

Supportive Periodontal TherapyPeriodontal MaintenanceAir PolishingTrehaloseUltrasonic InstrumentationPainPatient-Reported Outcomes

Outcome Measures

Primary Outcomes (1)

  • Pain perceived during supportive periodontal therapy

    Pain perceived by the participant during the supportive periodontal therapy session will be assessed using a Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). The outcome will be compared between participants treated with trehalose air-polishing and those treated with ultrasonic instrumentation.

    Immediately after the supportive periodontal therapy session

Secondary Outcomes (10)

  • Patient-reported treatment experience

    Immediately after each supportive periodontal therapy session

  • Duration of supportive periodontal therapy session

    At each supportive periodontal therapy visit throughout the 24-month follow-up

  • Adherence to supportive periodontal therapy

    Throughout the 24-month follow-up

  • Probing pocket depth (PPD)

    Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up

  • Clinical attachment level (CAL)

    Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up.

  • +5 more secondary outcomes

Study Arms (2)

Trehalose Air-Polishing Group

EXPERIMENTAL

Participants allocated to this group will receive supportive periodontal therapy (SPT) using an air-polishing device with low-abrasive trehalose powder for subgingival biofilm removal.

Device: Trehalose Air-Polishing

Ultrasonic Instrumentation Group

ACTIVE COMPARATOR

Participants allocated to this group will receive supportive periodontal therapy (SPT) using conventional ultrasonic instrumentation for subgingival biofilm and calculus removal.

Device: Ultrasonic Instrumentation

Interventions

Subgingival biofilm removal during supportive periodontal therapy using an air-polishing device with low-abrasive trehalose powder.

Trehalose Air-Polishing Group

Conventional subgingival debridement during supportive periodontal therapy using ultrasonic instrumentation.

Ultrasonic Instrumentation Group

Eligibility Criteria

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

You may qualify if:

  • Men or women aged 18 years or older who voluntarily agree to sign the informed consent form before any study-related procedure is performed.
  • ASA physical status I or II.
  • Initial diagnosis of Stage I-III periodontitis according to the 2017 World Workshop, periodontally treated and stabilized, and enrolled in a supportive periodontal therapy (SPT) program.
  • Non-smokers or light smokers (\<10 cigarettes/day).
  • Commitment to attend all follow-up visits over the 24-month study period.

You may not qualify if:

  • Patients requiring local anesthesia or anxiolytic premedication to undergo supportive periodontal therapy (SPT).
  • Patients with pacemakers, implantable cardioverter-defibrillators, or neurostimulators.
  • Pregnant women.
  • Patients with infectious respiratory diseases.
  • Patients with systemic diseases or neurological disorders that may alter pain perception.
  • Patients receiving medications that may influence pain perception (e.g., opioids or gabapentin).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Odontològic Universitat de Barcelona

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

PeriodontitisPain

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Edgar Martínez García, DDS

    University of Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Octavi Camps Font, DDS, MSc, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be blinded to treatment allocation. Due to the nature of the interventions, the operator performing supportive periodontal therapy cannot be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 12, 2026

First Posted

September 24, 2026

Study Start

October 1, 2026

Primary Completion

October 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

September 24, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared with external researchers, in accordance with the study protocol and applicable data protection regulations.

Locations