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

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional
• Participants enrolled: 30
• From 10 Jul 2024 to the primary completion date, 19 Jul 2025
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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