Guided Biofilm Therapy Compared to Traditional Cleaning for Treating Gingival Inflammation in Orthodontic Patients

Summary

Why is this study being done?

This study is for people with braces who have gum inflammation (gingivitis), which is when gums are swollen and bleed easily. Braces can make it harder to clean teeth, leading to a build-up of plaque (a sticky layer of germs).

The goal is to compare two different professional dental cleaning methods to see which one works better for people with braces.

What is the main question the study is trying to answer?

The main questions are:

Which cleaning method is better at removing plaque?

Which method leads to healthier gums (less bleeding and inflammation) after 2 weeks and 8 weeks?

The study will also look at:

How long each cleaning takes.

How comfortable or uncomfortable each method is for the participant.

Which method participants like better.

What methods are being compared?

Researchers will compare two methods:

Guided Biofilm Therapy (GBT): A newer method that uses a special powder with air to remove plaque, followed by a specific ultrasonic tool to remove any hard buildup.

Conventional Cleaning: The traditional method that uses an ultrasonic tool to clean the teeth, followed by polishing with a brush and paste.

How will the study work?

This is a "split-mouth" study. This means each participant will get both cleaning methods in one visit:

One side of the mouth will get the GBT cleaning.

The other side of the mouth will get the conventional cleaning.

The side that gets each treatment is chosen by chance (randomly). This lets researchers make a very fair comparison for each person.

Who can join this study?

Participants who:

Are between 18 and 40 years old.

Have braces on both their upper and lower teeth.

Have signs of gum inflammation (gingivitis).

Are in good general health and do not smoke.

Who cannot join this study?

Participants who:

Have severe gum disease (periodontitis).

Are pregnant or breastfeeding.

Are allergic to the cleaning materials (like erythritol or chlorhexidine).

Have had a professional gum treatment in the last 3 months.

What will participants be asked to do?

If you join this study, you will be asked to:

Come in for a first visit to check your gum health.

Receive both cleaning treatments (one on each side of your mouth) during the same visit.

Answer a short questionnaire after the cleaning about your comfort and which method you preferred.

Return for two follow-up checkups (at 2 weeks and 8 weeks) so researchers can check your gum health.

Conditions

• Gingivitis and Periodontal Diseases
• Gingivitis; Chronic
• Gingivitis
• Gingival Bleeding
• Periodontal Health
• Gingival Health

Interventions

DEVICE

Guided Biofilm Therapy

Guided Biofilm Therapy (GBT) focuses on the detection and targeted removal of dental biofilm. It was developed by EMS (Electro Medical Systems) and is claimed to be minimally invasive, gentle, and highly effective for both patients and practitioners. Key Features of GBT: Biofilm Detection: Uses disclosing agents to stain biofilm, making it visible for complete and accurate removal. Air Polishing (AIRFLOW®): A gentle, high-precision spray of air, water, and erythritol (or glycine) powder removes the biofilm. Subgingival Cleaning (PERIOFLOW®): Targets biofilm below the gingival margin and in periodontal pockets using a flexible nozzle and fine powder. Ultrasonic Debridement (PIEZON® NO PAIN): Removes remaining hard calculus with a piezoelectric scaler.

DEVICE

Traditional Ultrasonic Scaling + Polishing

Traditional ultrasonic scaling and polishing is a nonsurgical periodontal debridement procedure that utilizes an ultrasonic scaler-typically magnetostrictive or piezoelectric-to mechanically disrupt and remove dental calculus, dental plaque biofilm, and extrinsic stains. The procedure is followed by polishing using a bristle brush and prophylactic paste containing abrasive agents to remove extrinsic stains smooth enamel surfaces, reducing bacterial adhesion and improving esthetics. It is commonly performed as part of routine periodontal maintenance to prevent gingivitis and the progression of periodontitis.

Sponsors & Collaborators

• Jordan University of Science and Technology

  collaborator OTHER

• Deanship of Scientific Research/Jordan University of Science and Technology

  collaborator UNKNOWN

• King Abdullah University Hospital

  lead OTHER

Principal Investigators

• Reem Abdel-Hafez, Doctor of Clinical Dentistry · Jordan University of Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-10

Primary Completion

2025-07-19

Completion

2025-07-19

Countries

• Jordan

Study Locations