NCT07386925

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Feb 2026Nov 2026

First Submitted

Initial submission to the registry

January 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

January 28, 2026

Last Update Submit

January 28, 2026

Conditions

Pulpitis - ReversiblePulpotomies on Primary Molars

Keywords

Pelargonium graveolenspulpotomyMTA

Outcome Measures

Primary Outcomes (6)

  • absence of pain

    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

  • absence of fistula

    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

  • Tenderness to percussion

    Measuring Method: Percussion test Measuring Unite: Binary (+/-)

    up to 9 months

  • Furcation radiolucency

    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

    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

    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

Study Arms (2)

group 1: zinc oxide-geranium (Pelargonium graveolens) essential oil paste

EXPERIMENTAL

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

Procedure: pulpotomyProcedure: Radiation

group 2: MTA

ACTIVE COMPARATOR

30 primary molars will be treated with MTA to cover pulp stumps

Procedure: pulpotomyProcedure: Radiation

Interventions

pulpotomyPROCEDURE

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

group 1: zinc oxide-geranium (Pelargonium graveolens) essential oil pastegroup 2: MTA
RadiationPROCEDURE

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.

group 1: zinc oxide-geranium (Pelargonium graveolens) essential oil pastegroup 2: MTA

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • presence of spontaneous pain
  • presence of gingival swelling or sinus tract
  • presence of internal or external root resorption
  • pain on percussion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry, Tanta university

Tanta, Egypt

Location

Related Publications (2)

  • 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

    BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Interventions

PulpotomyRadiation

Intervention Hierarchy (Ancestors)

EndodonticsDentistryPhysical Phenomena

Study Officials

  • shimaa Hadwa

    shimaa.hadwa@dent.tanta.edu.eg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

shaimaa eldesouky, assistant professor

CONTACT

+201008994242shaimaaeldesouky@dent.tanta.edu.eg

nora Abo Shanady, lecturer

CONTACT

01091230999nora_aboshanady@dent.tanta.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of pediatric dentistry

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 4, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

February 4, 2026

Record last verified: 2026-01

Locations

EG(1)