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NCT07355517Befejeződött

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

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jan. 21.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
30 (tényleges)
Első benyújtás
2025. jún. 29.
Kezdés
2024. júl. 10.
Elsődleges befejezés
2025. júl. 19.
Fő szponzor
King Abdullah University Hospital
NCT-szám
NCT07355517

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 30
  • 2024. júl. 10. és az elsődleges befejezés (2025. júl. 19.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Received periodontal treatment within the last 3 months

Más betegség

  • Diagnosed with periodontitis or a history of periodontitis
  • Allergy to erythritol or chlorhexidine

Egyéb

  • Pregnant or lactating women
  • 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
  • Expected to complete orthodontic treatment before the end of the study
  • Unwillingness to undergo the proposed treatment or follow-up visits

Kiket keres a vizsgálat

  • 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

Életkor a regiszterben: 18 év – 40 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Jordan University of Science and TechnologyIrbidJordániaIsmeretlen állapot

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