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Clinical and Radiographic Success of Calcium Hydroxide-Iodoform Paste Versus Modified Triple Antibiotic Paste for Necrotic Primary Molars in Children

16 août 2026 mis à jour par: Yasmine Gamal Hafez Dawood Ghazaly, Cairo University

Assessment of the Clinical and Radiographic Success of Calcium Hydroxide Iodoform Paste Versus Modified Triple Antibiotic Paste for the Treatment of Necrotic Primary Molars Using LSTR Technique: A Randomized Clinical Trial

This randomized clinical trial aims to compare the clinical and radiographic success of calcium hydroxide-iodoform paste and modified triple antibiotic paste when used for the treatment of necrotic primary molars in children using the lesion sterilization and tissue repair (LSTR) technique. The study will include children aged 4-7 years with restorable necrotic mandibular second primary molars. Participants will be randomly assigned to receive LSTR treatment with either calcium hydroxide-iodoform paste or modified triple antibiotic paste. Clinical and radiographic findings will be assessed during follow-up over 12 months to determine the success of each treatment. The study hypothesis is that there will be a difference in the clinical and radiographic success between the two treatment materials when used with the LSTR technique

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

Necrotic primary teeth may present a clinical challenge in pediatric dentistry, particularly when the tooth is restorable and preservation of the primary tooth is desirable until its normal exfoliation. Infection of the root canal system may be associated with clinical and radiographic signs of periapical or furcation involvement. Conventional pulpectomy can be effective in the management of necrotic primary teeth; however, it may be technically demanding in young children because of the complex anatomy of primary molars, limited cooperation, and difficulties associated with instrumentation and obturation.

Lesion Sterilization and Tissue Repair (LSTR) is a minimally invasive approach that aims to control infection within the root canal system through the local application of antimicrobial agents, with minimal or no mechanical instrumentation of the canals. The rationale of LSTR is based on the polymicrobial nature of endodontic infection and the ability of antimicrobial materials to reduce or eliminate microorganisms within the infected root canal system. Following reduction of the microbial load, healing of the affected periradicular tissues may occur.

Calcium hydroxide-iodoform paste is an antimicrobial root canal filling material that combines the antibacterial properties of calcium hydroxide with the radiopacity and antimicrobial properties of iodoform. It has been widely used in primary tooth endodontic treatment because of its antimicrobial activity, radiopacity, and resorbability characteristics. Modified triple antibiotic paste is another antimicrobial approach consisting of a combination of antibiotics intended to provide activity against a broad range of microorganisms associated with endodontic infections.

The present study is designed as a randomized clinical trial to compare these two antimicrobial materials when used as part of the LSTR technique for the management of necrotic primary molars. The study will evaluate whether the use of calcium hydroxide-iodoform paste provides clinical and radiographic outcomes comparable to or different from those achieved with modified triple antibiotic paste.

Eligible participants will undergo clinical and radiographic assessment before treatment. Following confirmation of eligibility, participants will be randomly allocated to one of the two treatment groups. The first group will receive LSTR treatment using calcium hydroxide-iodoform paste, while the second group will receive LSTR treatment using modified triple antibiotic paste. Clinical and radiographic assessments will subsequently be performed during the predefined follow-up period.

The primary purpose of the study is to determine and compare the clinical and radiographic success of the two treatment approaches over the follow-up period. Clinical assessment will focus on the presence or absence of signs and symptoms associated with the treated tooth, while radiographic assessment will evaluate the status of the periradicular and furcation tissues and any changes in the pre-existing radiographic findings.

The study is intended to provide clinical evidence regarding the use of calcium hydroxide-iodoform paste as an alternative antimicrobial material for LSTR treatment of necrotic primary molars. The findings may contribute to the evidence base regarding minimally invasive treatment approaches for infected primary teeth and may help inform clinical decision-making in pediatric dentistry.

Type d'étude

Interventionnel

Inscription (Estimé)

50

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Pediatric patients aged 4-7 years
  • Positive parental informed consent
  • Restorable necrotic mandibular second primary molars with peri-radicular/furcal involvement and/or pathologic root resorption (external or internal one-third to two-thirds of the root)
  • Presence of chronic apical abscess or sinus tract or furcation radiolucency

Exclusion Criteria:

  • Medically compromised patient
  • Children with a known allergy to any of the components being utilized
  • Molars near exfoliation
  • Molars with severely resorbed roots more than two thirds, indicated for extraction
  • Molar with insufficient coronal structure disabling proper coronal seal
  • Presence of a periapical or interradicular radiolucent area which could compromise the permanent tooth bud

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Calcium Hydroxide-Iodoform Paste + LSTR
Participants assigned to this arm will receive lesion sterilization and tissue repair (LSTR) treatment using calcium hydroxide-iodoform paste as the antimicrobial material. The treatment will be performed according to the standardized clinical protocol, followed by clinical and radiographic evaluation during the 12-month follow-up period.
Médicament: Calcium Hydroxide, Iodoform, paste
Calcium hydroxide-iodoform paste will be used as the antimicrobial material for lesion sterilization and tissue repair (LSTR) treatment of necrotic primary molars. Following access to the pulp chamber and the clinical procedures specified in the study protocol, the paste will be placed into the prepared pulp chamber/canal orifices according to the standardized LSTR technique. The tooth will then be restored according to the study protocol. Participants will undergo clinical and radiographic follow-up for 12 months to assess treatment success.
Comparateur actif: Modified Triple Antibiotic Paste + LSTR
Participants assigned to this arm will receive lesion sterilization and tissue repair (LSTR) treatment using modified triple antibiotic paste as the antimicrobial material. The treatment will be performed according to the standardized clinical protocol, followed by clinical and radiographic evaluation during the 12-month follow-up period.
Médicament: modified triple antibiotic paste
Modified triple antibiotic paste will be used as the antimicrobial material for lesion sterilization and tissue repair (LSTR) treatment of necrotic primary molars. The paste will be prepared and applied according to the standardized formulation and clinical protocol specified in the study. Following access to the pulp chamber and the clinical procedures specified in the study protocol, the paste will be placed according to the LSTR technique. The tooth will then be restored according to the study protocol. Participants will undergo clinical and radiographic follow-up for 12 months to assess treatment success.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Pathological Mobility
Délai: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Tooth mobility will be assessed using Miller's Mobility Index, ranging from Grade 0 to Grade 3. Grade 0 indicates no clinically detectable mobility, while Grade 1 indicates slight horizontal mobility, Grade 2 indicates moderate horizontal mobility, and Grade 3 indicates severe mobility with both horizontal and vertical displacement. Higher grades indicate greater severity of pathological tooth mobility
Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Soft Tissue Pathologies
Délai: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Soft tissue pathologies will be assessed clinically by visual examination for the presence or absence of swelling, abscess, sinus tract, or fistula associated with the treated tooth. Each finding will be recorded as present or absent
Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Pain on Percussion
Délai: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Pain on percussion will be assessed clinically using a percussion test of the treated tooth. The response will be recorded as binary, indicating whether pain on percussion is present or absent.
Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Postoperative Pain
Délai: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Postoperative pain will be assessed by verbally questioning the participant regarding the presence of pain following treatment. The response will be recorded as binary, indicating whether postoperative pain is present or absent
Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Radiolucency at the periapical or furcation area
Délai: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Radiolucency in the periapical or furcation area will be assessed using standardized digital radiographs analyzed with DIGORA for Windows software. The finding will be recorded as binary, indicating whether periapical or furcation radiolucency is present or absent
Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Internal or External Root Resorption
Délai: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Internal or external root resorption will be assessed using standardized digital radiographs analyzed with DIGORA for Windows software. Root resorption will be recorded as binary, indicating whether internal or external root resorption is present or absent
Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Cairo University

Les enquêteurs

  • Chercheur principal: Prof.Dr.Rania Abdullah Nasr, PhD, Faculty of dentistry , Cairo university , Cairo , Giza , Egypt , 12613

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 janvier 2027

Achèvement primaire (Estimé)

1 janvier 2028

Achèvement de l'étude (Estimé)

1 janvier 2028

Dates d'inscription aux études

Première soumission

16 août 2026

Première soumission répondant aux critères de contrôle qualité

16 août 2026

Première publication (Réel)

19 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CU-PEDO-2026-001

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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