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

NCT07355517 | Completed

• 1 other identifier: 2024/80
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Gingivitis; Dental plaque; Oral hygiene; Periodontal health; Orthodontic appliances; Guided Biofilm Therapy; Scaling; Dental polishing; Scaling and polishing; Biofilm removal; Patient satisfaction; Treatment time; Clinical trial; Tooth cleaning; Non-surgical periodontal therapy; Preventive dentistry; Dental prophylaxis; Randomized controlled trial; Gingiva; Periodontium

Outcome Measures

Primary Outcomes (2)

• Change in Rustogi Modified Navy Plaque Index (RMNPI)

  The RMNPI is a detailed plaque scoring system that evaluates the buccal/labial surfaces of teeth by dividing each surface into nine distinct areas. Each area is scored dichotomously as 1 (plaque present) or 0 (plaque absent). In this study, due to the presence of orthodontic brackets, only four surfaces (mesial, distal, incisal, and gingival) will be evaluated, modifying the total number of assessed sections. The index is sensitive to small areas of plaque accumulation and provides data on incisal, gingival, and interproximal plaque levels. A plaque disclosing agent will be used prior to scoring. The Modified O'Leary Index will be used on lingual/palatal surfaces.

  Baseline, 2 weeks, 8 weeks

• Change in Bleeding on Probing Percentage (BoP%)

  BoP will be recorded dichotomously at six sites per tooth, and BoP% will be calculated as the percentage of bleeding sites relative to total measured sites.

  Baseline, 2 weeks, 8 weeks

Secondary Outcomes (3)

• Change in Gingival Index (GI)

  Baseline, 2 weeks, 8 weeks

• Change in Probing Depth (PD)

  Baseline, 2 weeks, 8 weeks

• Change in Plaque Index (Löe and Silness)

  Baseline, 2 weeks, 8 weeks

Other Outcomes (4)

• Total Treatment Time Per Side

  Day 1, postoperative

• Patient-Reported Pain/Discomfort Level

  Immediately post-treatment

• Patient-Reported Feeling of Cleanliness

  Immediately post-treatment

Study Arms (2)

Test: Guided Biofilm Therapy

EXPERIMENTAL

Treatment by Guided Biofilm Therapy (GBT). GBT treatment consists of supragingival and submarginal air polishing (Air-Flow Master Piezon®, EMS) with erythritol + chlorhexidine powder (PLUS®, EMS), followed by site-specific removal of calculus with ultrasonic piezoelectric scaler (Air-Flow Master Piezon®, EMS).

Device: Guided Biofilm Therapy

Control: Tradition Ultrasnoic Scaling + Polishing

ACTIVE COMPARATOR

Traditional ultrasonic debridement followed by polishing with a bristle brush and prophylactic paste.

Device: Traditional Ultrasonic Scaling + Polishing

Interventions

Traditional Ultrasonic Scaling + Polishing DEVICE

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.

Also known as: Traditional Non-surgical Periodontal Debridement and Polishing, Traditional Non-surgical Periodontal Debridement and Prophylaxis

Control: Tradition Ultrasnoic Scaling + Polishing

Guided Biofilm Therapy DEVICE

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.

Test: Guided Biofilm Therapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator
• Deanship of Scientific Research/Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan University of Science and Technology

Irbid, Irbid Governorate, 22110, Jordan

Location

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases; Bronchiolitis Obliterans Syndrome; Gingival Hemorrhage; Dental Plaque; Patient Satisfaction

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Oral Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dental Deposits; Tooth Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Reem Abdel-Hafez, Doctor of Clinical Dentistry

  Jordan University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Periodontology

Model Details: This study is conduct in a split mouth fashion, meaning each patient mouth is divided into halves, each half is then randomized to either the test or the control group. Therefore, the study is parallel deisgn, with one arm containing all the halves in the treatment group and the other arm containing the other

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: January 21, 2026
• Study Start: July 10, 2024
• Primary Completion: July 19, 2025
• Study Completion: July 19, 2025
• Last Updated: January 21, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

JO (1)