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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05812053
Other study ID # #R-PED-9-20-2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date April 2024

Study information

Verified date December 2023
Source Tanta University
Contact shaimaa eldesouky, lecturer
Phone +201008994242
Email shaimaaeldesouky@dent.tanta.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess & compare clinical & radiographic effects of Tea Tree Oil- Eggshell Powder and Biodentine as pulpotomy agents in primary teeth.


Description:

Pulpotomy is the most widely accepted technique for treating primary teeth with deep carious lesion, pulp exposure during the operatory process or after a traumatic pulp exposure. Mineral trioxide aggregate (MTA) is one such material that has shown tremendous potential for regeneration. Biodentineā„¢ (hydraulic silicate cement) is a novel dental material with high mechanical characteristics as well as superior biocompatibility and bioactive behaviour. Nowadays, chicken eggshell powder (CESP) (a natural calcium-rich source) is achieving wide acceptance in the medical and dental fields. Tea tree oil is the essential oil extracted from the Australian native Melaleuca alternifolia or the tea tree. To date, there is insufficient evidence to properly evaluate Tea Tree Oil- Eggshell Powder as a pulpotomy agent in primary teeth; thus, the current study aimed to assess and compare clinical and radiographical success of Tea Tree Oil- Eggshell Powder and Biodentine as pulpotomy agents in primary teeth.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date April 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 4 Years to 7 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
pulpotomy
Teeth will be anesthetized then Rubber dam and high suction will be used in pulpotomy procedure. Cavity outline was performed by sterile #330 high speed bur using water spray. Caries was removed by large spoon excavator. When pulpal exposure occurred, the roof of pulp chamber removed by low speed round bur. Haemostasis was obtained by applying pressure with moist cotton pellet with saline. Then the test materials was 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
Radiation:
cone beam computed tomography (CBCT) assessment
a post-operative CBCT image will be taken immediately after completing the procedure with fixed exposure parameters (120 Kv, 5mA, and 0.125mm voxel size) using the smallest field of view (8D, 8Hcm) also, after 6 and 12 months follow-up periods.

Locations

Country Name City State
Egypt Tanta University Tanta Gharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Celik BN, Mutluay MS, Arikan V, Sari S. The evaluation of MTA and Biodentine as a pulpotomy materials for carious exposures in primary teeth. Clin Oral Investig. 2019 Feb;23(2):661-666. doi: 10.1007/s00784-018-2472-4. Epub 2018 May 10. — View Citation

Hart PH, Brand C, Carson CF, Riley TV, Prager RH, Finlay-Jones JJ. Terpinen-4-ol, the main component of the essential oil of Melaleuca alternifolia (tea tree oil), suppresses inflammatory mediator production by activated human monocytes. Inflamm Res. 2000 Nov;49(11):619-26. doi: 10.1007/s000110050639. — View Citation

Kattimani VS, Chakravarthi PS, Kanumuru NR, Subbarao VV, Sidharthan A, Kumar TS, Prasad LK. Eggshell derived hydroxyapatite as bone graft substitute in the healing of maxillary cystic bone defects: a preliminary report. J Int Oral Health. 2014 Jun;6(3):15-9. Epub 2014 Jun 26. — View Citation

Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlinska J. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7. doi: 10.1016/j.joen.2013.01.005. Epub 2013 Apr 10. — View Citation

Siva Rama Krishna D, Siddharthan A, Seshadri SK, Sampath Kumar TS. A novel route for synthesis of nanocrystalline hydroxyapatite from eggshell waste. J Mater Sci Mater Med. 2007 Sep;18(9):1735-43. doi: 10.1007/s10856-007-3069-7. Epub 2007 May 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 months
Primary absence of fistula Measuring Method: Visual examination by operator Measuring Unite: score 0 for absence of swelling and score 1 for presence of swelling up to 12 months
Primary Tenderness to percussion Measuring Method: Percussion test Measuring Unite: Binary (+/-) Up to 12 month
Primary Furcation radiolucency Measuring Method: cone beam computed tomography (CBCT) for assessment of radio-density of bone at the furcation area Measuring Unite: Binary (+/-) 6 months
Primary Furcation radiolucency Measuring Method: cone beam computed tomography (CBCT) for assessment of radio-density of bone at the furcation area Measuring Unite: Binary (+/-) 12 months
See also
  Status Clinical Trial Phase
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Completed NCT03490422 - Pulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors N/A
Completed NCT04989036 - Biodentine Vital Pulpotomy in Immature Molars Phase 4
Completed NCT04052685 - Selective Removal to Soft Dentine vs Selective Removal to Firm Dentine for Deep Posterior Caries Lesions N/A
Enrolling by invitation NCT05397964 - Retrospective Evaluation of the Results of Direct Pulp Capping Treatment
Completed NCT03838068 - Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth Phase 2/Phase 3
Active, not recruiting NCT06171776 - Evaluation of Conservative Management of Teeth With Deep Cavitated Carious Lesions Phase 2/Phase 3
Recruiting NCT05878158 - Simvastatin Versus MTA in Pulpotomy of Immature Permanent Molars Early Phase 1