- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07814716
Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars
Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars: a Randomised Clinical Trial
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Hypomineralised second primary molars are more susceptible to post-eruptive enamel breakdown, carious lesions, hypersensitivity, and premature tooth loss. Although preformed stainless steel crowns have demonstrated favourable clinical performance in primary molars, orthodontic bands may represent a less invasive restorative approach for maintaining affected teeth until physiological exfoliation. However, their clinical performance in hypomineralised primary teeth has not been investigated.
This parallel-group randomised clinical trial will include 30 children presenting at least one hypomineralised second primary molar with extensive post-eruptive enamel breakdown or a cavitated carious lesion requiring restorative treatment. Participants will be randomly allocated to receive either an orthodontic band cemented with glass ionomer luting cement after restoration of the cavitated lesion or a preformed stainless steel crown placed using the Hall technique. When more than one tooth is eligible, one index tooth will be randomly selected for the primary analysis.
Clinical assessments will be performed immediately after treatment and at 6, 12, and 18 months. Marginal adaptation, retention, and carious lesions adjacent to the restoration margins will be assessed using modified United States Public Health Service criteria. Biofilm accumulation will be assessed using the Silness and Löe Plaque Index. Treatment acceptability will be evaluated immediately after treatment using separate questionnaires for children and caregivers. Physiological exfoliation during follow-up will be recorded separately and will not be considered treatment failure.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Rio Grande do Norte
-
Natal, Rio Grande do Norte, Brasilien, 59056-000
- Rekrytering
- Federal University of Rio Grande do Norte
-
Kontakt:
- Lavínia L. Costa, Master's
- Telefonnummer: +55 84 998987405
- E-post: lavinialourencocosta@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Children aged 5-10 years.
- Presence of at least one second primary molar affected by hypomineralised second primary molars requiring restorative treatment.
- Hypomineralisation associated with post-eruptive enamel breakdown involving more than one tooth surface or a cavitated carious lesion involving more than one surface and classified as code 5 or 6 according to the International Caries Detection and Assessment System.
Exclusion Criteria:
- Extensive carious lesion with subgingival margins.
- Clinical or radiographic signs of pulpal inflammation or necrosis.
- Advanced physiological root resorption indicating imminent exfoliation of the eligible tooth.
- Previous restorative treatment of the eligible tooth.
- Presence of bruxism.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Bands
Participants allocated to this arm will receive selective removal of softened carious dentine when carious tissue is present, followed by restoration of the cavity with conventional glass ionomer restorative cement (GC Gold Label 9).
A prefabricated stainless steel orthodontic band will then be adapted to the index tooth and cemented with glass ionomer luting cement (Meron).
|
Selective removal of softened carious dentine, when present, followed by restoration with conventional glass ionomer cement and placement of a prefabricated stainless steel orthodontic band cemented with glass ionomer luting cement.
|
|
Aktiv komparator: Crowns
articipants allocated to this arm will receive a preformed stainless steel crown placed using the Hall technique, without caries removal, local anaesthesia, or tooth preparation.
When a large cavity is present, glass ionomer restorative cement (GC Gold Label 9) will be placed at its base without prior caries removal.
The crown will be cemented with glass ionomer luting cement (Meron).
|
Placement of a preformed stainless steel crown using the Hall technique, without caries removal, local anaesthesia, or tooth preparation.
The crown will be cemented with glass ionomer luting cement.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Marginal adaptation
Tidsram: 18 months after treatment
|
Marginal adaptation will be assessed using modified United States Public Health Service criteria: Alpha, continuous margin without a detectable gap; Bravo, minor discontinuity not requiring clinical intervention; and Charlie, marginal defect requiring repair or replacement.
Alpha and Bravo will be considered clinically satisfactory, whereas Charlie will be considered a failure.
|
18 months after treatment
|
|
Retention
Tidsram: 18 months after treatment
|
Retention will be classified as Alpha when the orthodontic band or stainless steel crown remains firmly cemented and functional, or Charlie when it is lost or dislodged and requires recementation or replacement.
Alpha will be considered successful retention and Charlie a failure.
|
18 months after treatment
|
|
Presence of carious lesions
Tidsram: 18 months after treatment
|
Carious lesions adjacent to the restoration margins will be assessed clinically and classified as Alpha when absent or Charlie when present.
Alpha will be considered clinically satisfactory and Charlie a failure.
|
18 months after treatment
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Biofilm accumulation
Tidsram: Immediately after treatment and at 6, 12, and 18 months
|
Biofilm accumulation will be assessed using the Silness and Löe Plaque Index, ranging from 0 to 3: 0, absence of biofilm; 1, thin biofilm film along the free gingival margin; 2, moderate accumulation within the gingival sulcus; and 3, abundant accumulation within the gingival sulcus.
Lower scores indicate less biofilm accumulation.
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Immediately after treatment and at 6, 12, and 18 months
|
|
Child-reported treatment acceptability
Tidsram: Immediately after treatment
|
Acceptability will be assessed using a five-item questionnaire.
Each item will be scored from 0 to 4, resulting in a total score ranging from 0 to 20.
The negatively worded item will be reverse-scored.
Higher total scores indicate greater treatment acceptability.
|
Immediately after treatment
|
|
Caregiver-reported treatment acceptability
Tidsram: Immediately after treatment
|
Acceptability will be assessed using a five-item questionnaire.
Each item will be scored from 0 to 4, resulting in a total score ranging from 0 to 20.
Higher total scores indicate greater treatment acceptability.
|
Immediately after treatment
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- Bekes K, Steffen R, Kramer N. Hypomineralised second primary molars: the Wurzburg concept. Eur Arch Paediatr Dent. 2024 Aug;25(4):597-602. doi: 10.1007/s40368-024-00913-7. Epub 2024 May 28.
- Talekar AL, Waggoner WF, Silotry TMH, Musale PK, Chaudhari GS. Prospective, Randomized, Clinical Evaluation of Preformed Zirconia Crowns and Stainless Steel Crowns on Permanent First Molars: 12-Month Results. Pediatr Dent. 2023 May 15;45(3):232-239.
- Bagattoni S, Gozzi I, Lunardon C, Gatto MR, Piana G, Lardani L. Orthodontic Bands for Preventing Post-Eruptive Breakdown in Molars Affected by Molar Incisor Hypomineralisation. Eur J Paediatr Dent. 2025 Sep 1;26(3):212-217. doi: 10.23804/ejpd.2025.2380. Epub 2025 Apr 1.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 8.054.527
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