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

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