Effect of Different Adhesive Removal Techniques After Orthodontic Bracket Debonding on Postoperative Hypersensitivity: A Randomized Clinical Trial
The objective of this randomized clinical trial is to evaluate and compare the effect of four different residual adhesive removal techniques following orthodontic bracket debonding on postoperative tooth hypersensitivity. The study compares low-speed tungsten carbide burs against fiberglass burs, white stone burs, and rubber-impregnated polishing points. Postoperative hypersensitivity will be evaluated using a Visual Analogue Scale (VAS) with an air-blast stimulus test immediately after debonding, at 24 hours, and at 7 days follow-up.
Studienübersicht
Status
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Asmaa Badr Abdelfatah, BDS
- Telefonnummer: +20 1148106593
- E-Mail: asmaa.abdelfatah@dentistry.cu.edu.eg
Studieren Sie die Kontaktsicherung
- Name: Heba El-Deeb, PhD
- Telefonnummer: +20 106 610 9461
- E-Mail: heba.eldeeb@dentistry.cu.edu.eg
Studienorte
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Cairo, Ägypten
- Faculty of Dentistry, Cairo University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Patients of any gender aged 15 to 45 years undergoing routine fixed labial orthodontic bracket removal across anterior and premolar teeth in both jaws.
- Systemically healthy patients.
- Good oral hygiene with a healthy, intact periodontium without clinical attachment loss or gingival recession.
- Patients capable of reliably recording subjective discomfort on a Visual Analogue Scale (VAS) and willing to attend follow-up visits.
- Sound fully erupted permanent incisors, canines, and premolars bonded with conventional stainless steel labial brackets.
- Labial enamel surfaces free of visible pre-existing enamel defects, structural hypoplasia, severe fluorosis, or restorations.
Exclusion Criteria:
- Active use of systemic analgesics, NSAIDs, corticosteroids, or centrally acting pain medications within 14 days prior to debonding.
- Use of desensitizing toothpastes, mouthwashes, or topical fluoride varnishes within 30 days prior to the trial.
- Heavy bruxism, clenching habits, or pathological wear/erosion extending into dentin.
- Pregnant or lactating female patients.
- Teeth with irreversible pulpitis, pulpal necrosis, history of endodontic treatment, or periapical pathology.
- Teeth with active carious lesions or exposed cervical dentin/cementum.
- Teeth with severe, deep enamel microcracks identified at baseline examination.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Active Comparator: Low-Speed Tungsten Carbide Bur
Residual composite adhesive remnants on eligible teeth are cleaned using a 12-fluted low-speed tungsten carbide bur operated at 15,000-20,000 rpm under continuous water cooling. |
Composite resin is removed using a 12-fluted tapered low-speed tungsten carbide bur operated at 15,000-20,000 rpm under continuous air-water spray irrigation until all visible adhesive remnant is completely eliminated. |
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Experimental: Fiberglass Bur
Residual composite adhesive remnants on eligible teeth are cleaned using a fiberglass bur operated at 15,000-20,000 rpm under continuous water cooling |
Composite resin remnants are eliminated using a fiberglass resin-removal bur operated at 15,000-20,000 rpm under continuous air-water spray irrigation until all visible material is completely removed. |
|
Experimental: White Stone Bur
Residual composite adhesive remnants on eligible teeth are cleaned using a fine-grit white stone bur (aluminum oxide) operated at 10,000-15,000 rpm under continuous water cooling. |
Composite resin remnants are removed using a fine-grit Arkansas white stone bur (aluminum oxide) operated at 10,000-15,000 rpm under continuous air-water spray irrigation until the enamel surface is clear. |
|
Experimental: Rubber-Impregnated Polishing Point
Residual composite adhesive remnants on eligible teeth are cleaned using a rubber-impregnated polishing point operated at 10,000-15,000 rpm under continuous water cooling |
Residual adhesive tags are removed and polished using a rubber-impregnated composite polishing point operated at 10,000-15,000 rpm under continuous air-water spray irrigation |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Postoperative Hypersensitivity
Zeitfenster: Baseline (immediately post-debonding, before clean-up), 24 hours, and 7 days post-adhesive removal.
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Patient-reported pain and hypersensitivity evaluated using a Visual Analogue Scale (VAS) score ranging from 0 (No pain) to 10 (Unbearable severe pain) in response to a 2-second dental syringe air-blast stimulus test. |
Baseline (immediately post-debonding, before clean-up), 24 hours, and 7 days post-adhesive removal.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Procedure Time
Zeitfenster: Immediately during the clean-up procedure.
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Time taken to perform complete residual adhesive removal per tooth, measured using a stopwatch |
Immediately during the clean-up procedure.
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Heba El-Deeb, PhD, Cairo to Department of Conservative Dentistry, Faculty of Dentistry, Cairo University .
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CONS 3-4-1
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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