Faculty of Dentistry
Beirut, Rue de Damas, 0000, Lebanon
NCT Number: NCT07725276
The goal of this prospective clinical trial is to evaluate whether adding interproximal cleaning aids (interproximal brush, rubber toothpick, water flosser) to regular tooth brushing improves oral hygiene outcomes and gingival health compared with tooth brushing alone in dental students with gingivitis and intact interdental papillae. The main questions it aims to answer are:
* Does the addition of interproximal cleaning aids to tooth brushing result in greater reduction of dental plaque accumulation compared with tooth brushing alone? * Does the use of interproximal cleaning aids improve gingival bleeding outcomes compared with tooth brushing alone? * Does the use of interproximal cleaning aids affect interdental papilla health and cause soft tissue trauma or damage? * Do different interproximal cleaning aids influence participants' motivation and adherence to oral hygiene practices?
Researchers will compare tooth brushing alone with tooth brushing combined with three different interproximal cleaning aids (interdental brush, water flosser, and rubber toothpick) to determine whether these adjunctive methods provide additional benefits in plaque control, gingival health, preservation of interdental soft tissues, and participant motivation.
Participants will:
* Perform standardized tooth brushing using the modified Bass technique twice daily. * Use the assigned interproximal cleaning aid (interdental brush, water flosser, or rubber toothpick) in designated quadrants according to standardized instructions. * Attend clinical evaluations at baseline and after 7, 14, and 28 days. * Undergo assessment of dental plaque score, gingival bleeding score, interdental papilla condition, and motivation related to oral hygiene practices.
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Notify Me20 year–23 year
All sexes
Interventional
Not applicable
Beirut, Rue de Damas, 0000, Lebanon
This prospective split-mouth clinical trial aims to evaluate the effectiveness and safety of different interproximal cleaning aids used in addition to toothbrushing compared with toothbrushing alone in dental students diagnosed with gingivitis and presenting with intact interdental papillae.
The study will investigate whether toothbrushing alone, when performed using a standardized and effective technique, is sufficient for maintaining plaque control and gingival health, or whether the addition of interproximal cleaning devices provides further clinical benefits. The study will also assess the potential impact of these devices on interdental papilla integrity, possible soft tissue trauma, and participant motivation and adherence.
Participants will be dental students enrolled at Saint Joseph University of Beirut who meet the eligibility criteria. Eligible participants will present with gingivitis, intact interdental papillae, and no periodontal attachment loss or conditions that may interfere with periodontal health assessment. Participants with orthodontic appliances, crowns, implants, dentures, periodontitis, diastemas, systemic conditions affecting periodontal health, or medications causing gingival enlargement will be excluded.
Each participant's mouth will be divided into four quadrants in a split-mouth design. A computer-generated randomization sequence will determine the starting position of the assigned interventions to minimize site-related bias. Each quadrant will receive one of the following oral hygiene protocols:
All participants will receive standardized oral hygiene instructions and a dental kit containing a soft toothbrush, fluoride toothpaste, interproximal brush, water flosser, and rubber toothpick. Participants will perform the modified Bass toothbrushing technique twice daily, in the morning and after the last meal of the day, for a period of one month (4 weeks).
For the interproximal brush group, participants will perform gentle back-and-forth movements five times in each interdental space. For the water flosser group, participants will direct the irrigator tip along the gingival margin and interdental papillae using continuous flow mode while avoiding direct contact with gingival tissues. For the rubber toothpick group, participants will perform gentle back-and-forth movements five times in each interdental space.
Clinical evaluations will be performed at four time points:
The primary outcomes will include:
Secondary outcomes will include:
All clinical measurements will be performed by the same calibrated examiner using a Hu-Friedy PCPUNC 15 periodontal probe. The study will provide comparative data regarding the effectiveness, safety, and acceptability of commonly used interproximal cleaning devices in individuals with gingivitis and good oral hygiene skills.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants received standardized tooth brushing instructions using the Modified Bass technique twice daily after the last meal. No additional interproximal cleaning aid was used. This arm served as the control group for comparison with adjunctive interproximal cleaning interventions.
Participants used a water flosser as an adjunct to tooth brushing. The device was applied along the gingival margin using the continuous soft mode.
Participants used an interproximal brush as an adjunct to tooth brushing. The brush was inserted into interdental spaces and moved back and forth five times per site.
Participants used a rubber toothpick as an adjunct to tooth brushing for interdental cleaning according to the manufacturer's instructions.
Time frame: Baseline (T0), Day 7, Day 14, and Day 28.
The effectiveness of each oral hygiene intervention in reducing dental plaque accumulation will be assessed using the Quadrant Plaque Score (QPS), derived from the Full-Mouth Plaque Score (FMPS; O'Leary Plaque Index). The QPS is expressed as the percentage of tooth surfaces with visible dental plaque within each quadrant, with scores ranging from 0% to 100%. Higher scores indicate greater plaque accumulation (worse oral hygiene), whereas lower scores indicate less plaque accumulation (better oral hygiene). Plaque levels will be recorded at baseline (T0), 7 days (T7), 14 days (T14), and 28 days (T28). Changes in QPS over time will be compared between tooth brushing alone and tooth brushing combined with interproximal cleaning aids (interproximal brush, water flosser, and rubber toothpick).
Time frame: Baseline (T0), Day 7, Day 14, and Day 28.
he effect of each oral hygiene intervention on gingival inflammation will be assessed using the Quadrant Bleeding Score (QBS), derived from the Full-Mouth Bleeding Score (FMBS). The QBS is expressed as the percentage of periodontal sites exhibiting bleeding on probing within each quadrant, with scores ranging from 0% to 100%. Higher scores indicate greater gingival inflammation (worse gingival health), whereas lower scores indicate less gingival inflammation (better gingival health). Gingival bleeding will be recorded following periodontal probing at baseline (T0), 7 days (T7), 14 days (T14), and 28 days (T28) after the intervention. Changes in QBS over time will be compared between tooth brushing alone and tooth brushing combined with interproximal cleaning aids (interproximal brush, water flosser, and rubber toothpick).
Time frame: Baseline (T0), Day 7, Day 14, and Day 28.
The effect of each oral hygiene intervention on interdental soft tissue integrity will be assessed using the Papilla Harm (PH) score. The Papilla Harm score evaluates the presence and severity of interdental papillary trauma following the use of interproximal cleaning aids. Scores range from 0 to 4, where a score of 0 indicates no papillary trauma and higher scores indicate increasing severity of papillary injury (worse interdental soft tissue integrity). The presence and severity of papillary trauma will be evaluated at baseline (T0), 7 days (T7), 14 days (T14), and 28 days (T28) after the intervention. Changes in PH scores over time will be compared between tooth brushing alone and tooth brushing combined with interproximal cleaning aids (interproximal brush, water flosser, and rubber toothpick).
Time frame: Day 7, Day 14, and Day 28.
Participant-reported motivation and acceptance of each oral hygiene intervention will be assessed using a Numerical Rating Scale (NRS) ranging from 1 to 10. A score of 1 represents the lowest level of motivation/acceptance, while a score of 10 represents the highest level of motivation/acceptance. Higher scores indicate greater motivation and acceptance of the assigned cleaning method (better outcome), whereas lower scores indicate lower motivation and acceptance. Motivation scores will be recorded at 7 days (T7), 14 days (T14), and 28 days (T28) after the intervention. Differences in motivation levels between tooth brushing alone and tooth brushing combined with interproximal cleaning aids (interproximal brush, water flosser, and rubber toothpick) will be evaluated.
Saint-Joseph University
Other
Comparing the Efficacy of Toothbrushing With and Without Interproximal Cleaning Aids Among Dental Students: A Split-Mouth Clinical Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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