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Not yet recruiting NCT07386925

Pelargonium Graveolens Essential Oil as a Pulpotomy Agent in Primary Teeth

No phase Interventional Pulpitis - Reversible Pulpotomies on Primary Molars

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pulpotomy, Radiation.
Who it may be relevant to
Registry conditions: Pulpitis - Reversible, Pulpotomies on Primary Molars. Basic parameters: 4 years — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinical and Radiographic Evaluation of Pelargonium Graveolens Essential Oil as a Pulpotomy Agent in Primary Teeth

Overview

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.

Detailed description

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

Interventions

  • Procedure pulpotomy
    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 eac
  • Procedure Radiation
    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). T

Primary outcome measures

  • absence of pain [Time frame: up to 9 months]
  • absence of fistula [Time frame: up to 9 months]
  • Tenderness to percussion [Time frame: up to 9 months]
  • Furcation radiolucency [Time frame: 3 months]
  • furcation radiolucency [Time frame: 6 months]
  • furcation radiolucency [Time frame: 9 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • faculty of dentistry, Tanta university — Tanta

Publications

  • 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. PMID 15926290
  • 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.

Identifiers

NCT: NCT07386925 · # R-PED-12-25-3237

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗