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

NCT07773805 | Not Yet Recruiting

• 1 other identifier: CU-PEDO-2026-001
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dental Pulp Necrosis; Periapical Diseases; Dental Caries; Primary Teeth

Keywords

Lesion Sterilization and Tissue Repair; Dental Pulp Necrosis; Calcium Hydroxide-Iodoform Paste; Modified Triple Antibiotic Paste; Necrotic Primary Teeth

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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.

  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

  Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative

Secondary Outcomes (2)

• Radiolucency at the periapical or furcation area

  Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative

• Internal or External Root Resorption

  Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative

Study Arms (2)

Calcium Hydroxide-Iodoform Paste + LSTR

EXPERIMENTAL

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

Modified Triple Antibiotic Paste + LSTR

ACTIVE COMPARATOR

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

Interventions

Calcium Hydroxide, Iodoform, paste DRUG

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.

Calcium Hydroxide-Iodoform Paste + LSTR

modified triple antibiotic paste DRUG

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.

Modified Triple Antibiotic Paste + LSTR

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (20)

• Almarji W, Laflouf M, Tolibah YA. Evaluation of the modified 3Mix-Simvastatin combination in non-instrumental endodontic therapy of necrotic primary molars: A two-arm randomized controlled trial. Clin Exp Dent Res. 2024 Apr;10(2):e860. doi: 10.1002/cre2.860.

  PMID: 38433296 BACKGROUND

• Thakur S, Deep A, Singhal P, Chauhan D. A randomized control trial comparing the efficacy of 3Mixtatin and Modified 3Mix-MP paste using lesion sterilization and tissue repair technique to conventional root canal treatment in primary molars of children aged 4-8 years: An in vivo study. Dent Res J (Isfahan). 2021 Nov 22;18:93. doi: 10.4103/1735-3327.330874. eCollection 2021.

  PMID: 35003558 BACKGROUND

• Singh K, Reddy A, Arya A, Sridhar V, Ranjan M, Bulbule N. Lesion Sterilization Tissue Repair: A Review. J Pharm Bioallied Sci. 2024 Feb;16(Suppl 1):S75-S77. doi: 10.4103/jpbs.jpbs_411_23. Epub 2024 Feb 29.

  PMID: 38595433 BACKGROUND

• Shafi MK, Shah AA, Khan MA, Faisal S, Iqbal S. The Assessment and Efficiency of Cefixime in Upper Respiratory Tract Infections: Insights and Perspectives. Cureus. 2024 Jul 14;16(7):e64539. doi: 10.7759/cureus.64539. eCollection 2024 Jul.

  PMID: 39144897 BACKGROUND

• Sain S, J R, S A, George S, S Issac J, A John S. Lesion Sterilization and Tissue Repair-Current Concepts and Practices. Int J Clin Pediatr Dent. 2018 Sep-Oct;11(5):446-450. doi: 10.5005/jp-journals-10005-1555. Epub 2018 Oct 1.

  PMID: 30787561 BACKGROUND

• Sefa I, Garg N, Pathivada L, Yeluri R. Success of Lesion Sterilization and Tissue Repair Therapy and Pulpectomy in the Management of Infected Primary Molars with Poor Prognosis. Int J Clin Pediatr Dent. 2024 Jan;17(1):41-47. doi: 10.5005/jp-journals-10005-2750.

  PMID: 38559868 BACKGROUND

• Shankar K, Ramkumar H, Dhakshinamoorthy S, Paulindraraj S, Jayakaran TG, Bommareddy CS. Comparison of Modified Triple Antibiotic Paste in Two Concentrations for Lesion Sterilization and Tissue Repair in Primary Molars: An In Vivo Interventional Randomized Clinical Trial. Int J Clin Pediatr Dent. 2021 May-Jun;14(3):388-392. doi: 10.5005/jp-journals-10005-1951.

  PMID: 34720512 BACKGROUND

• M Ghorpad, T. (2024). Success Rate of Triple Antibiotic Paste for Lesion Sterilization and Tissue Repair Therapy in Primary Molars: A Systematic Review. World Journal of Dentistry, 14(12).

  BACKGROUND

• Li L, Yang X, Ju W, Li J, Yang X. Impact of primary molars with periapical disease on permanent successors: A retrospective radiographic study. Heliyon. 2023 Apr 28;9(5):e15854. doi: 10.1016/j.heliyon.2023.e15854. eCollection 2023 May.

  PMID: 37187910 BACKGROUND

• Govindaraju L, Jeevanandan G, Vishwanathaiah S, Maganur PCG. Clinical and radiographic success rate of the root canal filling materials used in primary teeth: A systematic review. Dent Med Probl. 2024 May-Jun;61(3):447-455. doi: 10.17219/dmp/152235.

  PMID: 38963396 BACKGROUND

• Estrela C, Estrela CR, Hollanda AC, Decurcio Dde A, Pecora JD. Influence of iodoform on antimicrobial potential of calcium hydroxide. J Appl Oral Sci. 2006 Jan;14(1):33-7. doi: 10.1590/s1678-77572006000100007.

  PMID: 19089027 BACKGROUND

• Barve A, Lakade L, Shah P, Chaudhary S, Jajoo S, Joshi G. Antibiotic Paste as an Intracanal Medicament in Infected Primary Teeth: A Systematic Review. Cureus. 2025 Apr 23;17(4):e82876. doi: 10.7759/cureus.82876. eCollection 2025 Apr.

  PMID: 40416098 BACKGROUND

• Amila Zukanović, Elmedin Bajrić, Marković, N., Damir Duratbegović, Katana, E., Emina Čengić, Senka Serhatlić and Hasan Pejak (2023). Lesion sterilization and tissue repair (LSTR) method in irreversible dental pulp changes of primary teeth. Balkan Journal of Dental Medicine, 27(1), pp.15-20. doi:10.5937/bjdm2301015z.

  BACKGROUND

• Alrayes N, Almaimouni Y, Tounsi A, Tarabzouni K, Alonaizan F, Salem Ibrahim M. The effect of an antibacterial mixture and non-instrumentation endodontic treatment in primary teeth: A systematic review and meta-analyses. Saudi Dent J. 2023 Sep;35(6):575-588. doi: 10.1016/j.sdentj.2023.06.001. Epub 2023 Jun 19.

  PMID: 37823084 BACKGROUND

• ali, I., Mohamed Ismai, A. A. D., Abbas, A. (2022). 'Clinical and Radiographic Evaluation of Different Obturating Materials as Biological Barrier in Quality of Obturation of Pulpectomized Primary Anterior Teeth', Al-Azhar Journal of Dental Science, 25(4), pp. 505-515. doi: 10.21608/ajdsm.2022.119687.1301

  BACKGROUND

• Ahuja, V., Ahuja, A., Verma, J., & Arunima. (2021). Apexification with apical growth and closure using Metapex in a Necrotic Immature Permanent Tooth with Periapical abscess: A Case Report with 16 months follow-up . UNIVERSITY JOURNAL OF DENTAL SCIENCES, 7(1). https://doi.org/10.21276/10.21276/ujds.2021.7.1.26

  BACKGROUND

• Khadilkar AS, Kapur A, Goyal A, Gauba K, Singh SK. Comparison of clinical performance of obturating materials in pulpectomies: A randomized clinical trial. J Indian Soc Pedod Prev Dent. 2024 Jan 1;42(1):28-36. doi: 10.4103/jisppd.jisppd_516_23. Epub 2024 Apr 15.

  PMID: 38616424 RESULT

• Baghlaf K, Alamoudi RA. Clinical and radiographic success of lesion sterilization and tissue repair in primary teeth: a systematic review and meta-analysis. Saudi Dent J. 2025 Oct 15;37(7-9):61. doi: 10.1007/s44445-025-00059-2.

  PMID: 41091393 RESULT

• Agarwal SR, Bendgude VD, Kakodkar P. Evaluation of Success Rate of Lesion Sterilization and Tissue Repair Compared to Vitapex in Pulpally Involved Primary Teeth: A Systematic Review. J Conserv Dent. 2019 Nov-Dec;22(6):510-515. doi: 10.4103/JCD.JCD_76_20. Epub 2020 Aug 20.

  PMID: 33088056 RESULT

• Achanta A, Reche A, Dakhale R, Bharate RR. A Comprehensive Review of Lesion Sterilization and Tissue Repair: An Alternative for Pulpectomy in Deciduous Teeth. Cureus. 2023 Nov 3;15(11):e48218. doi: 10.7759/cureus.48218. eCollection 2023 Nov.

  PMID: 38054133 RESULT

MeSH Terms

Conditions

Dental Pulp Necrosis; Periapical Diseases; Dental Caries

Interventions

Calcium Hydroxide; iodoform; Ointments

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Tooth Demineralization

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Prof.Dr.Rania Abdullah Nasr, PhD

  Faculty of dentistry , Cairo university , Cairo , Giza , Egypt , 12613

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmine Gamal Hafez Dawood Ghazaly, B.D.S faculty of dentistry

CONTACT

+201204444443; yasmine.ghazaly@dentistry.cu.edu.eg

Prof.Dr.Osama EL Shahawy Chief supervisor, PhD

CONTACT

+201005634755; osama.shahawy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to treatment allocation. The care provider administering the intervention will not be blinded because knowledge of the assigned treatment material is required for treatment administration
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student, Department of Pediatric Dentistry

Model Details: This is a prospective, parallel-group, randomized clinical trial with a 1:1 allocation ratio. Participants will be randomly assigned to one of two treatment groups and followed prospectively for 12 months.

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: August 19, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share