Gingivitis and Periodontal DiseasesNCT07355517
Guided Biofilm Therapy Compared to Traditional Cleaning for Treating Gingival Inflammation in Orthodontic Patients
A study testing Guided Biofilm Therapy and Traditional Ultrasonic Scaling + Polishing in people with Gingivitis and Periodontal Diseases and Gingivitis; Chronic, run by King Abdullah University Hospital at 1 site in Jordan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis and Periodontal Diseases, Gingivitis; Chronic, Gingivitis
- What is being tested?
- Guided Biofilm Therapy and Traditional Ultrasonic Scaling + Polishing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJordan
- Study dates
- 10 Jul 2024to 19 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Jordan1 site
Jordan University of Science and Technology
Irbid, Irbid Governorate, 22110
About this study
Official title: Guided Biofilm Therapy Versus Conventional Ultrasonic Debridement and Polishing for the Treatment of Gingivitis in Patients With Fixed Orthodontic Appliances: A Split-Mouth Randomized Controlled Clinical Trial
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Gingivitis and Periodontal Diseases, Gingivitis; Chronic, Gingivitis, Gingival Bleeding, Periodontal Health, Gingival Health
- Being tested
- Guided Biofilm Therapy, Traditional Ultrasonic Scaling + Polishing
- 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
- Medical subject headings
- Gingivitis, Periodontal Diseases, Bronchiolitis Obliterans Syndrome, Gingival Hemorrhage, Dental Plaque, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Biofilm TherapyDevice
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.
Traditional Ultrasonic Scaling + PolishingDevice
Also called Traditional Non-surgical Periodontal Debridement and Polishing, Traditional Non-surgical Periodontal Debridement and Prophylaxis
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Guided Biofilm Therapy |
| Control: Tradition Ultrasnoic Scaling + Polishing | Active comparator | Traditional ultrasonic debridement followed by polishing with a bristle brush and prophylactic paste. Receives: Device: Traditional Ultrasonic Scaling + Polishing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 2 weeks, 8 weeks
Secondary outcomes (3)
Change in Gingival Index (GI)
The Gingival Index by Löe and Silness measures gingival inflammation based on color, consistency, and bleeding on probing. Scoring is as follows:
0 = Normal gingiva
- = Mild inflammation (slight change in color, slight edema, no bleeding on probing)
- = Moderate inflammation (redness, edema, glazing, bleeding on probing)
- = Severe inflammation (marked redness and edema, ulceration, spontaneous bleeding)
Measured: Baseline, 2 weeks, 8 weeks
Change in Probing Depth (PD)
Periodontal probing depth will be measured at six points per tooth using a calibrated periodontal probe. The distance (in mm) from the gingival margin to the base of the periodontal pocket will be recorded.
Measured: Baseline, 2 weeks, 8 weeks
Change in Plaque Index (Löe and Silness)
The Löe and Silness Plaque Index evaluates the thickness of plaque at the gingival margin of the tooth. It is scored on a scale from 0 to 3:
0 = No plaque
- = A film of plaque adhering to the free gingival margin and adjacent area of the tooth, visible only by disclosing solution or by running a probe across the surface
- = Moderate accumulation of soft deposits visible to the naked eye
- = Abundance of soft matter This index will be used on the lingual/palatal surfaces of teeth using disclosing agents.
Measured: Baseline, 2 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start10 Jul 2024
- Primary completion19 Jul 2025
- Study completion19 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingivitis and Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology, Deanship of Scientific Research/Jordan University of Science and Technology
- Responsible party
- Principal investigator, Reem Abdel-Hafez, Jordan University of Science and Technology
- Investigators
- Reem Abdel-Hafez, Doctor of Clinical Dentistry, Study chair, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355517
- Sponsor's protocol ID
- 2024/80
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Biofilm Therapy Versus Conventional Ultrasonic Debridement and Polishing for the Treatment of Gingivitis in Patients With Fixed Orthodontic Appliances: A Split-Mouth Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07355517
- Acronym / sponsor ID
- 2024/80
- Conditions
- Gingivitis and Periodontal Diseases, Gingivitis; Chronic, Gingivitis, Gingival Bleeding, Periodontal Health, Gingival Health
- Keywords
- Gingivitis, Dental plaque, Oral hygiene, Periodontal health, Orthodontic appliances, Guided Biofilm Therapy, Scaling, Dental polishing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology, Deanship of Scientific Research/Jordan University of Science and Technology
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 19 Jul 2025 (actual)
- Study completion
- 19 Jul 2025 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Test: Guided Biofilm Therapy | Experimental | Device: Guided Biofilm TherapyTreatment 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). |
| Control: Tradition Ultrasnoic Scaling + Polishing | Active comparator | Device: Traditional Ultrasonic Scaling + PolishingTraditional ultrasonic debridement followed by polishing with a bristle brush and prophylactic paste. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Biofilm TherapyGuided 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. | Device | Test: Guided Biofilm Therapy |
| Traditional Ultrasonic Scaling + PolishingAlso: Traditional Non-surgical Periodontal Debridement and Polishing, Traditional Non-surgical Periodontal Debridement and ProphylaxisTraditional 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. | Device | Control: Tradition Ultrasnoic Scaling + Polishing |
Primary outcome
Change in Rustogi Modified Navy Plaque Index (RMNPI)
Time frame: Baseline, 2 weeks, 8 weeks
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.
Change in Bleeding on Probing Percentage (BoP%)
Time frame: Baseline, 2 weeks, 8 weeks
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.
3 secondary outcomes
Change in Gingival Index (GI)
Time frame: Baseline, 2 weeks, 8 weeks
Change in Probing Depth (PD)
Time frame: Baseline, 2 weeks, 8 weeks
Change in Plaque Index (Löe and Silness)
Time frame: Baseline, 2 weeks, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reem Abdel-Hafez, Doctor of Clinical Dentistry study chair
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Biofilm Therapy and Traditional Ultrasonic Scaling + Polishing in people with Gingivitis and Periodontal Diseases and Gingivitis; Chronic, run by King Abdullah University Hospital at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Rustogi Modified Navy Plaque Index (RMNPI) (time frame: Baseline, 2 weeks, 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.