NCT07355517

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

Completed NA Last updated 21 January 2026

What this trial tests

NA trial testing Guided Biofilm Therapy in Gingivitis and Periodontal Diseases in 30 participants. Completed in 19 July 2025.

Timeline

10 July 2024

Primary endpoint
19 July 2025

19 July 2025

Quick facts

Lead sponsor	King Abdullah University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	30
Start date	10 July 2024
Primary completion	19 July 2025
Estimated completion	19 July 2025
Sites	1 location across Jordan

Drugs / interventions tested

• Guided Biofilm Therapy
• Traditional Ultrasonic Scaling + Polishing

Conditions studied

• Gingivitis and Periodontal Diseases — all drugs for Gingivitis and Periodontal Diseases →
• Gingivitis; Chronic — all drugs for Gingivitis; Chronic →
• Gingivitis — all drugs for Gingivitis →
• Gingival Bleeding — all drugs for Gingival Bleeding →

Sponsor

King Abdullah University Hospital

Who can join

Adults 18 to 40, any sex, with Gingivitis and Periodontal Diseases or Gingivitis; Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.