NCT06835452

Brief Summary

Our study aimed to compare the effectiveness of current subgingival debridement methods used in the treatment of Stage 1 and Stage 2 periodontitis patients, the aesthetic condition achieved after these treatments, and the pain felt during treatment. 90 female patients who were diagnosed with chronic periodontitis (Stage 1-2) and required supra-subgingival scaling for treatment purposes, and who volunteered to participate in the study, were included in the study. Three treatment groups were determined. 30 people were included in each group. Periodontal examination was performed before and after the treatments in the 1st month, 3rd month and 6th month and the data on the collected periodontal parameters were analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

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

July 24, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 14, 2025

Last Update Submit

February 14, 2025

Conditions

Keywords

guided biofilm therapyperiodontitissubgingival debridement

Outcome Measures

Primary Outcomes (1)

  • Gingival index

    4 surfaces of all teeth (distal, buccal, mesial, lingual) are evaluated 0= Normal gingiva 1. Mild inflammation - slight discoloration, slight edema. There is no bleeding after probing. 2. Moderate inflammation - redness, edema and shine. Bleeding after probing. 3. Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding.

    baseline, 1st month, 3rd month and 6th month

Study Arms (3)

Group 1- classic treatment

Subgingival debridement was performed using the Cavitron and Gracey curette (this is the method that is used routinely).

Group 2-Guided Biofilm Therapy

Subgingival debridement was performed with the Guided Biofilm Therapy (GBT+Airabrasion) method. This method is the most up-to-date method. The biofilm is shown to the patient with plate dye, and the biofilm is cleaned with air abrasion and perio flow (EMS device cavitron). In the patient's control sessions, the patient's oral hygiene motivation is tried to be increased by dyeing the biofilm.

Group 3- Classical treatment and with Plaque paint

the dental calculus and biofilm were stained with plaque paint, shown to the patient with the help of a mirror, and then routine subgingival debridement was performed.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

90 female patients with stage 1-2 periodontitis

You may qualify if:

  • Systemically healthy patient (without known chronic disease)
  • Periodontal diagnostic data (Gingival Index, Plaque Index, Periodontal pocket depths, Attachment loss, Radiological data-Bone loss data) are complete
  • Treatments diagnosed with stage 1-2 periodontitis and those who have not had periodontal treatment in the last 6 months

You may not qualify if:

  • Having a systemic disease
  • Pregnant and lactating women
  • smoker
  • Those who do not want to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nigde Omer Halisdemir University

Niğde, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant prof

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 19, 2025

Study Start

July 24, 2024

Primary Completion

February 1, 2025

Study Completion

February 7, 2025

Last Updated

February 19, 2025

Record last verified: 2025-02

Locations