An interventional study of Calcium Hydroxide, Iodoform, paste and modified triple antibiotic paste in Dental Pulp Necrosis, Periapical Diseases and Dental Caries, sponsored by Cairo University. Not yet recruiting. Open to participants aged 4 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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
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.
156 studies on the registry are indexed under Dental Pulp Necrosis; 43 are open to participants now.
This study's planned enrollment of 50 is above the median of 45 across 147 interventional studies indexed under Dental Pulp Necrosis.
Browse Dental Pulp Necrosis studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Calcium Hydroxide, Iodoform, paste
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.
Drug: modified triple antibiotic paste
Drug pages: Calcium Hydroxide · Iodoform
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.
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.
Pathological Mobility
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
Time frame: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Soft Tissue Pathologies
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
Time frame: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Pain on Percussion
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.
Time frame: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Postoperative Pain
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
Time frame: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Radiolucency at the periapical or furcation area
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
Time frame: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
Internal or External Root Resorption
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
Time frame: Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
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Plan to share: No
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Studies of the drugs tested here: Calcium Hydroxide · Iodoform