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.
Studie Overzicht
Toestand
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Asmaa Badr Abdelfatah, BDS
- Telefoonnummer: +20 1148106593
- E-mail: asmaa.abdelfatah@dentistry.cu.edu.eg
Studie Contact Back-up
- Naam: Heba El-Deeb, PhD
- Telefoonnummer: +20 106 610 9461
- E-mail: heba.eldeeb@dentistry.cu.edu.eg
Studie Locaties
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Cairo, Egypte
- Faculty of Dentistry, Cairo University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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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Experimenteel: 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. |
|
Experimenteel: 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. |
|
Experimenteel: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Postoperative Hypersensitivity
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Procedure Time
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Heba El-Deeb, PhD, Cairo to Department of Conservative Dentistry, Faculty of Dentistry, Cairo University .
Studie record data
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Studie voltooiing (Geschat)
Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CONS 3-4-1
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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