Pelargonium Graveolens Etherische Olie als Pulpotomie Agent in Melktanden
Klinische en radiografische evaluatie van Pelargonium Graveolens etherische olie als pulpotomiemiddel in melktanden
The success of pulpotomy in primary teeth is critical for preserving function and arch integrity in children and depends largely on the biological properties of the medicament used. Given the limitations of mineral trioxide aggregate, Pelargonium graveolens essential oil has emerged as a potential alternative; however, its clinical performance as a pulpotomy agent remains insufficiently investigated.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
The use of medicinal plants and herbal extracts in modern dentistry is steadily increasing, primarily due to their antimicrobial properties and high biocompatibility. Pelargonium graveolens (rose geranium), native to South Africa, produces an essential oil rich in geraniol, citronellol, and linalool[18]. Geraniol, present in rose geranium oil, is recognized for its antioxidant, anti-inflammatory, antimicrobial, and anticancer effects. The oil's main constituents, beta-citronellol and geraniol, contribute to its antifungal and wound-healing properties, making it a promising agent for treating denture-induced stomatitis
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: shaimaa eldesouky, assistant professor
- Telefoonnummer: +201008994242
- E-mail: shaimaaeldesouky@dent.tanta.edu.eg
Studie Contact Back-up
- Naam: nora Abo Shanady, lecturer
- Telefoonnummer: 01091230999
- E-mail: nora_aboshanady@dent.tanta.edu.eg
Studie Locaties
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-
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Tanta, Egypte
- Nog niet aan het werven
- faculty of dentistry, Tanta university
-
Contact:
- shaimaa eldesouky, assistant professor
- Telefoonnummer: 01008994242
- E-mail: shaimaaeldesouky@dent.tanta.edu.eg
-
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Cairo Governorate
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Tanta, Cairo Governorate, Egypte, 31527
- Werving
- faculty of dentistry, Tanta university
-
Contact:
- shaimaa eldesouky, assistant professor
- Telefoonnummer: 01008994242
- E-mail: shaimaaeldesouky@dent.tanta.edu.eg
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Restorable primary molars with deep carious lesions.
- Absence of gingival swelling or sinus tract.
- Absence of spontaneous pain
- Absence of pain on percussion.
- Absence of discontinuity of lamina dura
- Absence of internal root resorption.
- Absence of external root resorption.
- Absence of inter-radicular or periapical bone destruction (radiolucency).
Exclusion Criteria:
- presence of spontaneous pain
- presence of gingival swelling or sinus tract
- presence of internal or external root resorption
- pain on percussion.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: group 2: MTA
30 primary molars will be treated with MTA to cover pulp stumps |
Radiographic evaluation will be performed immediately after teeth restoration (baseline radiograph), then after three, six, and twelve months for the furcation radiolucency area and bone radiodensity. A photo-simulated phosphorus plate sensor was used to take direct standardized digital radiographs. The parallel periapical technique was obtained by Rinn, which is attached to the X-ray tube with its arm fastened to the film holder that contained a coated PSP (photo-stimulated phosphorus plate). To ensure standardization during radiographic film retakes, condensation rubber base impression material will be positioned on the outside of the film holder, and the child is told to bite on it while the material is set. The sensor wil exposed to an X-ray machine (Planmeca ProX, Helsinki, Finland) with a central ray perpendicular to the sensor at 70 kVp, 6 mA, and 0.8 s. Radio-densitometric and radiometric analysis of the radiographs will be performed by RadiAnt software. Teeth will be anesthetized then Rubber dam and high suction will be used in pulpotomy procedure. Cavity outline will be performed by sterile #330 high speed bur using water spray. Caries will be removed by large spoon excavator. When pulpal exposure occurred, the roof of pulp chamber will be removed by low speed round bur. Haemostasis will be obtained by applying pressure with a moist cotton pellet with saline. Then the test materials will be applied. after that, pulp stumps of all molars in each group will be dressed using Intermediate restorative material, then the tooth will be restored with a preformed stainless steel crown |
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Experimenteel: group 1: zinc oxide-geranium (Pelargonium graveolens) essential oil paste
30 primary molars will be treated with geranium (Pelargonium graveolens) essential oil freshly mixed with zinc oxide powder till it reaches a suitable consistency (1:1 ratio by volume) to cover pulp stumps |
Radiographic evaluation will be performed immediately after teeth restoration (baseline radiograph), then after three, six, and twelve months for the furcation radiolucency area and bone radiodensity. A photo-simulated phosphorus plate sensor was used to take direct standardized digital radiographs. The parallel periapical technique was obtained by Rinn, which is attached to the X-ray tube with its arm fastened to the film holder that contained a coated PSP (photo-stimulated phosphorus plate). To ensure standardization during radiographic film retakes, condensation rubber base impression material will be positioned on the outside of the film holder, and the child is told to bite on it while the material is set. The sensor wil exposed to an X-ray machine (Planmeca ProX, Helsinki, Finland) with a central ray perpendicular to the sensor at 70 kVp, 6 mA, and 0.8 s. Radio-densitometric and radiometric analysis of the radiographs will be performed by RadiAnt software. Teeth will be anesthetized then Rubber dam and high suction will be used in pulpotomy procedure. Cavity outline will be performed by sterile #330 high speed bur using water spray. Caries will be removed by large spoon excavator. When pulpal exposure occurred, the roof of pulp chamber will be removed by low speed round bur. Haemostasis will be obtained by applying pressure with a moist cotton pellet with saline. Then the test materials will be applied. after that, pulp stumps of all molars in each group will be dressed using Intermediate restorative material, then the tooth will be restored with a preformed stainless steel crown |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
absence of pain
Tijdsspanne: up to 9 months
|
Measuring Method: Verbal Question to Patient /Parents Measuring Unite: score 0 for absence of pain and score 1 for presence of pain |
up to 9 months
|
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Tenderness to percussion
Tijdsspanne: up to 9 months
|
Measuring Method: Percussion test Measuring Unite: Binary (+/-) |
up to 9 months
|
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Furcation radiolucency
Tijdsspanne: 3 months
|
Measuring Method: periapical x-ray for assessment of radio-density of bone at the furcation area, Measuring Unit: mean value of gray level (which measures density scale between 0 to 256, with zero being the lowest value and 256 the highest dense value) |
3 months
|
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furcation radiolucency
Tijdsspanne: 6 months
|
Measuring Method: periapical x-ray for assessment of radio-density of bone at the furcation area, Measuring Unit: mean value of gray level (which measures density scale between 0 to 256, with zero being the lowest value and 256 the highest dense value) |
6 months
|
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furcation radiolucency
Tijdsspanne: 9 months
|
Description: Measuring Method: periapical x-ray for assessment of radio-density of bone at the furcation area, Measuring Unit: mean value of gray level (which measures density scale between 0 to 256, with zero being the lowest value and 256 the highest dense value) |
9 months
|
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absence of fistula
Tijdsspanne: up to 9 months
|
Measuring Method: Visual examination by operator Measuring Unit: score 0 for absence of swelling and score 1 for presence of swelling |
up to 9 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: shimaa Hadwa, shimaa.hadwa@dent.tanta.edu.eg
Publicaties en nuttige links
Algemene publicaties
- Holan G, Eidelman E, Fuks AB. Long-term evaluation of pulpotomy in primary molars using mineral trioxide aggregate or formocresol. Pediatr Dent. 2005 Mar-Apr;27(2):129-36.
- Subramanyam, D. and S. Somasundaram, Clinical and radiographic outcome of herbal medicine versus standard pulpotomy medicaments in primary molars: a systematic review. J Clin Diagn Res, 2017. 11(10): p. ZE12-ZE16.
Studie record data
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Studie voltooiing (Geschat)
Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- # R-PED-12-25-3237
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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