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.

This randomized split-mouth controlled clinical trial is designed to assess the comparative effectiveness of Guided Biofilm Therapy (GBT) and conventional ultrasonic debridement with bristle brush polishing in patients with fixed orthodontic appliances. The trial specifically evaluates the reduction of dental plaque accumulation, gingival inflammation, treatment duration, potential adverse effects, and patient-reported outcomes such as comfort and satisfaction.

Conventional treatment will consist of full-mouth ultrasonic debridement performed with a piezoelectric scaler (frequency range 28-32 kHz, standard tip for supra- and subgingival instrumentation), followed by polishing with a nylon bristle brush mounted on a low-speed handpiece and prophylactic paste. GBT will be performed according to the standardized EMS protocol. Supragingival and subgingival air-polishing will be conducted using erythritol + 0.3% chlorhexidine powder (PLUS®, EMS, particle size <14 µm) delivered by the Air-Flow Master Piezon® device. Site-specific calculus removal will then be performed using piezoelectric instrumentation with slim tips designed for subgingival access.

At baseline, plaque disclosure will be performed using EIMS-DV 158 biofilm disclosing agents, followed by digital photographs to document biofilm distribution. Clinical indices will include plaque accumulation recorded using the Rustogi Modified Navy Plaque Index (RMNPI) and the Modified O'Leary Index, gingival inflammation assessed by the Löe and Silness Gingival Index, and bleeding on probing (BoP) recorded dichotomously at six sites per tooth. Randomization will assign one side of the mouth to GBT and the contralateral side to conventional treatment. Each treatment session will be timed using a digital stopwatch, with plaque removal endpoints recorded. Any additional instrumentation required to achieve complete plaque removal will be documented.

All clinical procedures will be performed by calibrated periodontists. Calibration will be achieved by duplicate assessment of at least 10 patients not included in the trial until intra- and inter-examiner reliability reach a kappa value of ≥0.80 for all indices. Standardized instruments and consumables will be used throughout the study to minimize variability.

Following the professional intervention, participants will receive standardized oral hygiene instructions that include the use of a soft manual toothbrush (soft bristle, end-rounded filaments) and interdental brushes selected according to embrasure size. A structured questionnaire will be administered immediately after treatment to assess perceived pain or discomfort, treatment tolerability, perceived oral cleanliness, and preference between the two modalities using a validated 5-point Likert scale.

Clinical re-evaluations will be performed at 2 weeks and 8 weeks. The same indices (plaque, gingival inflammation, BoP) will be reassessed by calibrated examiners. Oral hygiene instructions will be reinforced at each visit.

The trial will be conducted in accordance with the Declaration of Helsinki (2013) and Good Clinical Practice (GCP) guidelines. Approval has been granted by the Institutional Review Board (IRB) of Jordan University of Science and Technology. Written informed consent will be obtained from all participants prior to enrollment. Adverse events will be documented, monitored, and reported according to IRB requirements.

Inclusion Criteria:

• Aged between 18 and 40 years
• Presence of fixed orthodontic appliances in both upper and lower arches for at least 1 month
• Diagnosed with generalized biofilm-induced gingivitis (defined as Bleeding on Probing (BoP) > 30% of sites)
• Presence of a minimum of 10 teeth per side
• Systemically healthy
• Non-smoker
• Motivated and able to maintain good oral hygiene
• Willing and able to provide written informed consent

Exclusion Criteria:

• Diagnosed with periodontitis or a history of periodontitis
• Pregnant or lactating women
• Allergy to erythritol or chlorhexidine
• Presence of dental caries or overhanging restorations
• Presence of more than 6 teeth with gingival enlargement grade II or III according to the Angelopoulos and Goaz Index
• Received periodontal treatment within the last 3 months
• Expected to complete orthodontic treatment before the end of the study
• Unwillingness to undergo the proposed treatment or follow-up visits

We plan to share de-identified individual participant data (IPD) including demographics, primary and secondary outcome measures, and adverse events. Data will be made available beginning 12 months after publication of the primary results, and will be accessible to qualified researchers upon reasonable request, subject to data-sharing agreements and IRB approval.

12 months after publication of primary results and will remain available for 5 years via a controlled access repository upon request and data use agreement.

Qualified researchers affiliated with academic institutions, healthcare organizations, or nonprofit research centers will be able to request access to the de-identified individual participant data (IPD) and supporting documents, including the Study Protocol, Statistical Analysis Plan (SAP), and Analytic Code.

Requests for access will be reviewed by the study sponsor or data access committee to ensure appropriate use and ethical standards.

Approved users will receive access via a secure online data repository, after signing a data use agreement that outlines terms of use, privacy protections, and publication rights.