Evaluation of Pulpotomy Techniques (Formocresol, Ferric Sulphate, Mineral Trioxide Aggregate) (MTA)
Evaluation of Pulpotomy Techniques (Formocresol ,Ferric Sulphate, Mineral Trioxide Aggregate)
The goal of this interventional study is to evaluate the different materials used for pulpotomy procedures in deciduous molars. this will help us find out which medicament is more effective in releving which medicament is more effective in releving pain and resolution of signs of infection.it will help us find out less chair time for procedure and cooperation of child .
調査の概要
詳細な説明
This interventional study will randomly allocate patients in three groups ( Formocresol, Ferric Sulphate , Mineral trioxide aggregate) based on the inclusion criteria procedure will be started by local local anesthesia with 2% lignocaine. Once anesthesia is achieved caries removal and access opening will be done with a round carbide bur number 6 or 8 and 330 respectively. Coronal pulp tissue will be removed by sharp spoon excavator. Hemostasis will be achieved with a sterile cotton pellet soaked with saline.Teeth in which hemostasis could not be achieved with in 5 minutes will be excluded from the study.these initial steps will be same for all three groups wile subsequent steps will varry according to the treatment group.
For formocresol group a sterile cotton pellet soaked with formocrsol will be placed on radicular pulp stumps for 5 minutes and then removed. Later the pulp stumps will be covered by zinoxide eugenol cement and tooth restored with glass ionomer cement.
For ferric suplahte a solution of 15.5% will be applied on sterile cotton and placed on pulp stumps for 15 seconds .later the pulp stumps will be covered by zinc oxide eugenol cement and tooth restored with glass ionomer cement.
For mineral trioxide aggregate pulpotomy pulp stumps will be covered with mineral trioxide aggregate and tooth will be restored with glass ionomer cement.
Patient will then be recalled for follow up at 2 weeks ,1 month and 6 months. Assessment will be done clinically and radiographically to determine treatment sucess and failure.
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：HUMA ZAHIR, FCPS
- 電話番号：923360119081
- メール：HUMA.ZAHIR@FUI.EDU.PK
研究連絡先のバックアップ
- 名前：SANA QASIM, BDS
- 電話番号：03338885560
- メール：SANAQASIM@HOTMAIL.COM
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
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Symptomless carious teeth with vital pulp exposure
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No clinical sign/symptoms of spontaneous and nocturnal pain, and tenderness to percussion or palpation, history of swelling or sinus tracts, pathologic mobility.
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Teeth restorable.
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No radiographic evidence of pulp degeneration such as internal or external resorption, inter-radicular or periapical bone destruction.
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No clinical evidence of pulp degeneration such as excessive bleeding from root canals.
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Teeth having no more than one third of their roots undergoing physiologic resorption.
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Exclusion Criteria:
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Teeth diagnosed with irreversible pulpitis
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Teeth having Pulp necrosis / periapical abscess
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Teeth with previous pulp therapy(pulpotomy/pulpectomy)
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Children with systemic medical conditions that may affect healing or contraindicate treatment.
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Children with special healthcare needs
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Children with known allergy to any of the materials used in the study.
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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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：PULPOTOMY MATERIAL
3 GROUPS GROUP 1:FORMOCRESOL,GROUP 2:FERRIC SULPHATE,GROUP 3 :MINERAL TRIOXIDE AGGREGATE |
FORMOCRESOL PULPOTOMY MATERIAL FOR 5MINUTES PACKED WITH STERILE COTTON PELLETS ON PULP STUMPS FERRIC SULPHATE 15.5 % PACKED ON PULP STUMPS WITH STERILE COTTON PELLET FOR 15 SECONDS. MINERAL TRIOXIDE AGGREGATE PLACED ON PULP STUPMS
他の名前：
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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 |
|---|---|---|
|
PAIN RELIEF
時間枠：2WEEKS ,1 MONTH ,6 MONTHS
|
PAIN RELIEF ASSESMENT BY SCALE 0-10 (O no pain ,1-3 mild pain, 4-7 moderate pain ,8-10 extreme pain) |
2WEEKS ,1 MONTH ,6 MONTHS
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Igna A. Vital pulp therapy in primary dentition: Pulpotomy-a 100-year challenge. Children. 2021;8(10). 2. A randomized controlled trial comparing - PubMed Mobile [Internet]. Available from: http://www.ncbi.nlm.nih.gov/m/pubmed/20801246/?i=4&from=leaver+maher 3. Roy S, Garg N, Pathivada L, Choudhary R, Kaur H, Yeluri R. Comparative Evaluation of Low-level Diode Laser and Electrosurgical Pulpotomy in Primary Molars. Int J Clin Pediatr Dent. 2023;16(4):612-8. 4. Tewari N, Goel S, Mathur VP, O'Connell AC, Johnson RM, Rahul M, et al. Success of medicaments and techniques for pulpotomy of primary teeth: An overview of systematic reviews. Int J Paediatr Dent. 2022;32(6):828-42. 5. Eshghi A, Hajiahmadi M, Nikbakht MH, Esmaeili M. Comparison of Clinical and Radiographic Success between MTA and Biodentine in Pulpotomy of Primary Mandibular Second Molars with Irreversible Pulpitis: A Randomized Double-Blind Clinical Trial. Int J Dent. 2022;2022. 6. Philip N, Cherian JM, Mathew MG, Thomas AM, Jodhka S, John N, et al. Treatment outcomes of pulpotomy versus pulpectomy in vital primary molars diagnosed with symptomatic irreversible pulpitis: protocol for a non-inferiority randomised controlled trial. BMC Oral Health [Internet]. 2024;24(1):1-10. Available from: https://doi.org/10.1186/s12903-024-04411-6 7. Yildiz E, Tosun G. Evaluation of formocresol , calcium hydroxide , ferric sulfate , and MTA primary molar pulpotomies. 2019;8(2). 8. Guo J, Zhang N, Cheng Y. Comparative efficacy of medicaments or techniques for pulpotomy of primary molars: a network meta-analysis. Clin Oral Investig. 2023;27(1):91-104. 9. Simonoska J, Bjelica R, Dimkov A, Simjanovska J, Gabrić D, Gjorgievska E. Efficacy of Laser Pulpotomy vs. Conventional Vital Pulpotomy in Primary Teeth: A Comparative Clinical Analysis. Children. 2025;12(3):1-11. 10. Pulpotomy E. Original Article. 2018;
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- FUCD-PEADS- 2601
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
PATIENT CONFIDENTIALITY NEEDS TO BE MAINTAINED.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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