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Segmented Indirect Versus Direct Bracket Bonding

30. září 2026 aktualizováno: Omar Alkadhi, Riyadh Elm University

Bond Failure of a Segmented Modified Indirect Bonding Technique Versus Direct Bonding: A Randomized Clinical Trial

This randomized clinical trial compared two methods of attaching orthodontic brackets to teeth: conventional direct bonding, in which each bracket is placed and bonded individually in the mouth, and a segmented modified indirect bonding technique, in which brackets are first positioned on a plaster model of the patient's teeth and then transferred to the mouth in segments using a hot-glue transfer tray. The purpose was to find out whether the two techniques differ in how often brackets come loose (bond failure) during treatment.

Eighteen patients receiving fixed orthodontic appliances at Riyadh Elm University, Riyadh, Saudi Arabia, were randomly assigned so that their brackets were placed by either the direct or the modified indirect technique. The same bracket type and adhesive were used in both groups. Patients were examined every four weeks for six months, and any bracket that debonded was recorded along with the tooth involved, the arch (upper or lower), the side (right or left), and the time from bonding to failure. The main outcome was the time from bonding to bracket failure; the investigators also compared failure rates and examined whether failure varied by tooth type, arch, or side.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Background and rationale: Direct bonding, in which orthodontic brackets are positioned and light-cured individually on each tooth, remains the most common technique but depends heavily on operator visibility and isolation at the moment of placement, which is constrained on posterior teeth. Indirect bonding positions brackets on a working cast under direct vision and transfers them to the dentition in a tray, and has been proposed to improve placement and reduce chairside time. Whether indirect bonding reduces clinical bond failure compared with direct bonding is not established, and clinical failure data for low-cost analogue (hot-glue) transfer-tray methods are limited.

Objective: To compare time to bracket bond failure (primary outcome) and bond-failure rate (secondary outcome) between conventional direct bonding and a segmented modified indirect bonding technique, and to examine whether failure varied by tooth type, arch, or side.

Design: Prospective, parallel-arm, single-center randomized clinical trial. Participants were allocated by simple randomization from a computer-generated sequence to direct bonding or segmented modified indirect bonding. The trial was open-label, as the bonding technique could not be masked from the operator.

Setting: Orthodontic clinics, Riyadh Elm University, Riyadh, Saudi Arabia. Participants: Patients seeking fixed-appliance orthodontic treatment were screened against eligibility criteria. Patients with overbite greater than 3 mm; with crowns, bridges, veneers, restorations, or enamel hypoplasia on the teeth to be bonded; with severely rotated or blocked-out teeth; or with partially erupted teeth were excluded. Eighteen participants were enrolled after written informed consent.

Interventions: In the direct group, teeth were pumiced, etched with 37% phosphoric acid (Meta Etchant, Meta Biomed), rinsed thoroughly, and excess water was removed; Ortho Solo Universal Sealant and Bond Enhancer (Ormco) was applied, and brackets were bonded with Enlight light-cured adhesive (Ormco), then light-cured for 20 seconds occlusally and 20 seconds gingivally. In the modified indirect group, alginate impressions were poured in dental stone; brackets were fixed to the casts in planned positions; segmented transfer trays (separate segments for molars, premolar-canine, and lateral/central incisors per quadrant) were fabricated with thermal (hot) glue covering the occlusal and partial lingual surfaces, leaving the bracket exposed below the slot. Teeth were pumiced, etched with the same 37% phosphoric acid, rinsed thoroughly, and excess water was removed; Ortho Solo Universal Sealant and Bond Enhancer was applied to the etched teeth and Enlight adhesive to the bracket bases before tray insertion; the trays were then seated and light-cured for 20 seconds before removal. The same bracket type and adhesive system were used in both arms.

Outcomes: The primary outcome was time to bracket bond failure (days from bonding to first debonding); the secondary outcome was the bond-failure rate. Each event was recorded with the tooth, arch (maxilla/mandible), side (right/left), date, and time from bonding to failure in days. The unit of analysis was the individual bracket. Participants were reviewed every four weeks for six months; debonded brackets were re-bonded directly.

Analysis: Time to failure was analysed with Kaplan-Meier estimates, the log-rank test and Cox proportional-hazards regression. Failure rates were compared with chi-square and exact tests and Firth penalized logistic regression, with an exploratory Holm-corrected analysis of technique by tooth type and side.

Typ studie

Intervenční

Zápis (Aktuální)

18

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Riyadh Region
      • Riyadh, Riyadh Region, Saudská arábie, 12734
        • Riyadh Elm university

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Patients seeking fixed-appliance orthodontic treatment
  • Permanent dentition
  • Teeth to be bonded free of crowns, bridges, veneers, restorations, or enamel hypoplasia

Exclusion Criteria:

  • Overbite greater than 3 mm
  • Teeth with crowns, bridges, veneers, restorations, or enamel hypoplasia
  • Severely rotated or blocked-out teeth
  • Partially erupted teeth

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Direct bonding

Orthodontic brackets were bonded directly onto each tooth in the mouth. Teeth were pumiced, etched with 37% phosphoric acid (Meta Etchant, Meta Biomed), rinsed thoroughly, and excess water was removed. Ortho Solo Universal Sealant and Bond Enhancer (Ormco) was applied to the teeth, and each bracket was seated with Enlight light-cured adhesive (Ormco) along the tooth's long axis, vertical height, and mesiodistal midline, then light-cured for 20 seconds occlusally and 20 seconds gingivally. This arm comprised 160 brackets.

Orthodontic brackets bonded individually onto each tooth intraorally. Teeth were pumiced, etched with 37% phosphoric acid (Meta Etchant, Meta Biomed), rinsed thoroughly, and excess water was removed; Ortho Solo Universal Sealant and Bond Enhancer (Ormco) was applied to the teeth, and each bracket was seated with Enlight light-cured adhesive (Ormco) along the tooth's long axis, vertical height, and mesiodistal midline, then light-cured for 20 seconds occlusally and 20 seconds gingivally. The same bracket type and adhesive system were used as in the experimental arm.

Experimentální: Segmented modified indirect bonding

Orthodontic brackets were first positioned on a dental stone cast in their planned locations, then transferred to the teeth using segmented hot-glue transfer trays (separate segments for molars, premolar-canine, and lateral and central incisors in each quadrant). Teeth were pumiced, etched with 37% phosphoric acid (Meta Etchant, Meta Biomed), rinsed thoroughly, and excess water was removed. Ortho Solo Universal Sealant and Bond Enhancer (Ormco) was applied to the etched teeth and Enlight light-cured adhesive (Ormco) to the bracket bases; the tray was then seated, light-cured for 20 seconds, and removed. This arm comprised 224 brackets.

Orthodontic brackets positioned on a dental stone cast in their planned locations and transferred to the teeth using segmented hot-glue (thermal-glue) transfer trays, fabricated separately for molar, premolar-canine, and lateral and central incisor segments in each quadrant. Teeth were pumiced, etched with 37% phosphoric acid (Meta Etchant, Meta Biomed), rinsed thoroughly, and excess water was removed; Ortho Solo Universal Sealant and Bond Enhancer (Ormco) was applied to the etched teeth and Enlight light-cured adhesive (Ormco) to the bracket bases before tray insertion; the tray was then seated, light-cured for 20 seconds, and removed. The same bracket type and adhesive system were used as in the comparator arm.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to bracket bond failure (time to debond)
Časové okno: 6 months from bonding

For each bonded bracket, the number of days from bracket placement (bonding) to the first bond failure (debonding). A bracket still bonded at the end of follow-up is right-censored at the date of its last assessment. Only the first failure per bracket is the event; debonded brackets that were re-bonded are not re-entered.

6 months from bonding

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to failure among debonded brackets
Časové okno: 6 months from bonding

For brackets that debonded, the time interval from initial bonding to the recorded failure, measured in days.

6 months from bonding
Bracket bond failure rate
Časové okno: 6 months from bonding

Proportion of bonded brackets that debonded (bond failure) during the follow-up period. Each tooth was examined at four-weekly recall visits; a bracket was recorded as failed if it had detached from the tooth. Failure was assessed at the individual-bracket level and expressed as the percentage of brackets that debonded in each group.

6 months from bonding
Bracket bond failure by tooth type, arch, and side
Časové okno: 6 months from bonding

Bracket bond-failure rate compared across tooth type (incisor, canine, premolar, molar), arch (maxilla, mandible), and side (right, left), to assess whether failure varied by bracket location.

6 months from bonding

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Vyšetřovatelé

  • Ředitel studie: Omar H Alkadhi, Orthodontist, Riyadh Elm University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

22. listopadu 2020

Primární dokončení (Aktuální)

19. října 2021

Dokončení studie (Aktuální)

19. října 2021

Termíny zápisu do studia

První předloženo

31. května 2026

První předloženo, které splnilo kritéria kontroly kvality

30. září 2026

První zveřejněno (Aktuální)

6. října 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. října 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • FPGRP/2020/525/334/328

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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