NCT07847736

Brief Summary

This study compared immediate pain perception following manual and ultrasonic supragingival periodontal debridement in patients with plaque-induced gingivitis. It also evaluated whether dental anxiety, pain catastrophizing, and general pain sensitivity were associated with pain experienced during periodontal instrumentation. Participants underwent either manual supragingival debridement using hand instruments or ultrasonic supragingival debridement. Before treatment, dental anxiety, pain catastrophizing, and pain sensitivity were assessed using validated questionnaires. Immediately after the procedure, participants rated their pain intensity using a visual analog scale (VAS). The study aimed to determine whether immediate pain perception differed between the two instrumentation methods and to examine the contribution of individual psychological and pain-related characteristics to perceived pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2026

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

Keywords

Periodontal DebridementUltrasonic InstrumentationManual InstrumentationPain PerceptionDental AnxietyPain CatastrophizingPain SensitivityVisual Analog Scale

Outcome Measures

Primary Outcomes (1)

  • Immediate Pain Intensity Assessed by Visual Analog Scale (VAS)

    Immediately after supragingival debridement, participants rated the pain experienced during the procedure using a Visual Analog Scale (VAS). Higher scores indicated greater perceived pain intensity.

    Immediately after completion of supragingival debridement

Study Arms (2)

Manual Supragingival Debridement

ACTIVE COMPARATOR

Participants underwent full-mouth supragingival debridement using manual periodontal instruments.

Procedure: Manual Supragingival Debridement

Ultrasonic Supragingival Debridement

ACTIVE COMPARATOR

Participants underwent full-mouth supragingival debridement using an ultrasonic periodontal device.

Procedure: Ultrasonic Supragingival Debridement

Interventions

Full-mouth supragingival debridement was performed using manual periodontal instruments (scalers and curettes) to remove supragingival plaque and calculus.

Manual Supragingival Debridement

Full-mouth supragingival debridement was performed using an ultrasonic periodontal device with water irrigation to remove supragingival plaque and calculus.

Ultrasonic Supragingival Debridement

Eligibility Criteria

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

You may qualify if:

  • Aged 18-65 years
  • Systemically healthy
  • Diagnosed with gingivitis according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions
  • Having an indication for non-surgical periodontal treatment
  • Willing to participate in the study

You may not qualify if:

  • Presence of any systemic disease
  • Use of analgesic, antidepressant, or anxiolytic medications
  • Pregnancy or breastfeeding
  • Periodontal treatment within the previous 6 months
  • Presence of neurological or psychiatric disorders that may affect pain perception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University, Faculty of Dentistry, Department of Periodontology

Rize, Rize Province, 53020, Turkey (Türkiye)

Location

Study Officials

  • SEMİH ALPEREN BOSTAN, DDS, PhD

    Recep Tayyip Erdogan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were assigned to either manual or ultrasonic supragingival debridement in an alternating sequence according to the order of enrollment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 29, 2026

Study Start

August 1, 2026

Primary Completion

September 15, 2026

Study Completion

September 15, 2026

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be publicly shared due to participant confidentiality and data protection considerations.

Locations