Clinical and Radiographic Success of Calcium Hydroxide-Iodoform Paste Versus Modified Triple Antibiotic Paste for Necrotic Primary Molars in Children
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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Prof.Dr.Osama EL Shahawy Chief supervisor, PhD
- 電話番号：+201005634755
- メール：osama.shahawy@dentistry.cu.edu.eg
研究連絡先のバックアップ
- 名前：Yasmine Gamal Hafez Dawood Ghazaly, B.D.S faculty of dentistry
- 電話番号：+201204444443
- メール：yasmine.ghazaly@dentistry.cu.edu.eg
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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アクティブコンパレータ：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.
|
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pathological Mobility
時間枠：Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
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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
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Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
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Soft Tissue Pathologies
時間枠：Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
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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
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Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
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Pain on Percussion
時間枠：Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
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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.
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Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
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Postoperative Pain
時間枠：Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
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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
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Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Radiolucency at the periapical or furcation area
時間枠：Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
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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
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Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
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Internal or External Root Resorption
時間枠：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
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Baseline (pre-operative), 3 months post-operative, 6 months post-operative, 9 months post-operative, 12 months post-operative
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Prof.Dr.Rania Abdullah Nasr, PhD、Faculty of dentistry , Cairo university , Cairo , Giza , Egypt , 12613
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- 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.
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その他の研究ID番号
- CU-PEDO-2026-001
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