Clinical Comparison of Cariclast Gel and Rotary Drilling Technique for Caries Removal in 2d Primary Molars

Официальное название

Clinical Evaluation of Pain Perception and Patient Acceptance During Chemomechanical Caries Removal Using Cariclast Versus Conventional Caries Removal in 2nd Primary Molars With Occlusal Caries in Children: A Randomized Clinical Trial

Обзор

This randomized clinical trial aims to compare two different methods of caries removal in primary molars: the chemomechanical technique using Cariclast gel and the conventional rotary drilling method. The study will evaluate and compare the pain perception, patient acceptance, and operative time associated with both techniques in children aged 5-7years.

Подробное описание

Dental caries is one of the most common chronic diseases in children, and the management of carious lesions in primary teeth should be both effective and minimally invasive. Traditional caries removal using rotary instruments is associated with discomfort and anxiety among pediatric patients.

Chemomechanical caries removal (CMCR) agents such as Cariclast have been developed as a more conservative and less traumatic alternative. Cariclast works by softening the infected dentin chemically, allowing its gentle removal without pain or vibration.

This randomized controlled clinical trial will compare Cariclast with the conventional rotary drilling method regarding:

Pain perception assessed using the FLACC scale.

Patient acceptance evaluated using the Visual Analog Scale (VAS).

Operative time required to complete the caries removal procedure.

All procedures will be performed on cooperative children with occlusal caries in primary molars, without pulpal involvement, attending the Pediatric Dentistry Department, Faculty of Dentistry, Cairo University.

Вмешательства

• Процедура cares removal using cariclast gel
  Chemomechanical caries removal using Cariclast gel applied to soften infected dentin, followed by gentle excavation with hand instruments.
• Процедура Conventional Mechanical Caries Removal
  Conventional mechanical caries removal performed using a high-speed rotary handpiece under adequate water cooling, following standard clinical principles for primary molars.

Первичные конечные точки

• Pain Perception During Caries Removal [Срок оценки: During the caries removal procedure (immediate intraoperative assessment)]

Вторичные конечные точки (1)

• Child Acceptance of the Caries Removal Technique [Срок оценки: Immediately after the procedure]

Критерии участия

Критерии включения

• Children:

• children aged 4-7 years
• in good general health, and medically free according to parent history.
• Cooperative patients
• Children whom their parents will comply with follow-ups.
• Children whom their parents who accept to sign informed consent

Tooth:

• Broad cavitated occlusal lesion with dentinal involvement
• (Black's Class I cavity) and occlusal access.
• Radiograph showing dentinal caries up to two-thirds of the dentinal thickness.
• The consistency of carious lesions ranges from soft to medium hard.
• Color of carious lesion ranges from light yellow to brown

Критерии исключения

• Children:

• Medically or developmentally compromising conditions
• Children who will be unable to attend follow-up visits.
• Children whom their parents refuse to give written formed consent.

Teeth:

• Cases requiring restorative treatment that is not of the Class I variety.
• Extensively damaged teeth.
• Radiograph showing dentinal caries of more than two thirds of the dentinal thickness.
• Caries involving pulp or extending below the gingiva.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Gupta N, Marwah N, Nigam A, Vishwanathaiah S, Alessa N, Almeslet A, Alhakami K, Dawood T, Masha FM, Maganur PC. Evaluation of Papacarie(R), Carie-Care, BRIX3000 and conventional hand instrumentation for caries removal in primary teeth: a randomized control study. J Clin Pediatr Dent. 2024 May;48(3):131-138. doi: 10.22514/jocpd.2024.066. Epub 2024 May 3. PMID 38755991
• Nagaveni, N. B., Radhika, N. B., Satisha, T. S., Ashwini, K. S., Sridhar, N., & Gupta, S. (2016). Efficacy of new chemomechanical caries removal agent compared with conventional method in primary teeth: An in vivo study. International Journal of Oral Health Sciences, 6(2), 52-58. doi: 10.4103/2231-6027.199986
• Cardoso M, Coelho A, Lima R, Amaro I, Paula A, Marto CM, Sousa J, Spagnuolo G, Marques Ferreira M, Carrilho E. Efficacy and Patient's Acceptance of Alternative Methods for Caries Removal-a Systematic Review. J Clin Med. 2020 Oct 23;9(11):3407. doi: 10.3390/jcm9113407. PMID 33114249
• Al Agili DE. A systematic review of population-based dental caries studies among children in Saudi Arabia. Saudi Dent J. 2013 Jan;25(1):3-11. doi: 10.1016/j.sdentj.2012.10.002. Epub 2012 Nov 10. PMID 23960549
• Chaussain-Miller C, Decup F, Domejean-Orliaguet S, Gillet D, Guigand M, Kaleka R, Laboux O, Lafont J, Medioni E, Serfaty R, Toumelin-Chemla F, Tubiana J, Lasfargues JJ. Clinical evaluation of the Carisolv chemomechanical caries removal technique according to the site/stage concept, a revised caries classification system. Clin Oral Investig. 2003 Mar;7(1):32-7. doi: 10.1007/s00784-003-0196-5. Epub PMID 12673435
• Kotb RM, Abdella AA, El Kateb MA, Ahmed AM. Clinical evaluation of Papacarie in primary teeth. J Clin Pediatr Dent. 2009 Winter;34(2):117-23. doi: 10.17796/jcpd.34.2.f312p36g18463716. PMID 20297701

Идентификаторы

NCT: NCT07270458 · NK2025-CARICLAST

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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