- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07386925
Pelargonium Graveolens Essential Oil as a Pulpotomy Agent in Primary Teeth
January 28, 2026 updated by: Shaimaa Shaban Mohamed El-desouky, Tanta University
Clinical and Radiographic Evaluation of Pelargonium Graveolens Essential Oil as a Pulpotomy Agent in Primary Teeth
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: shaimaa eldesouky, assistant professor
- Phone Number: +201008994242
- Email: shaimaaeldesouky@dent.tanta.edu.eg
Study Contact Backup
- Name: nora Abo Shanady, lecturer
- Phone Number: 01091230999
- Email: nora_aboshanady@dent.tanta.edu.eg
Study Locations
-
-
-
Tanta, Egypt
- Faculty of Dentistry, Tanta University
-
Contact:
- shaimaa eldesouky, assistant professor
- Phone Number: 01008994242
- Email: shaimaaeldesouky@dent.tanta.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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
|
|
Experimental: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
absence of pain
Time Frame: 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
|
|
Tenderness to percussion
Time Frame: up to 9 months
|
Measuring Method: Percussion test Measuring Unite: Binary (+/-)
|
up to 9 months
|
|
Furcation radiolucency
Time Frame: 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
|
|
furcation radiolucency
Time Frame: 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
|
|
furcation radiolucency
Time Frame: 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
|
|
absence of fistula
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: shimaa Hadwa, shimaa.hadwa@dent.tanta.edu.eg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Holan, G., E. Eidelman, and A.B. Fuks, Long-term evaluation of pulpotomy in primary molars using mineral trioxide aggregate or formocresol. Pediatric dentistry, 2005. 27(2): p. 129-136
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2026
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
November 1, 2026
Study Registration Dates
First Submitted
January 28, 2026
First Submitted That Met QC Criteria
January 28, 2026
First Posted (Actual)
February 4, 2026
Study Record Updates
Last Update Posted (Actual)
February 4, 2026
Last Update Submitted That Met QC Criteria
January 28, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- # R-PED-12-25-3237
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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