Comparative Evaluation of Eggshell Powder in Primary Teeth Pulpotomy

Pulp Exposure, Dental Clinical Trial

Official title:

Comparative Evaluation of Eggshell Powder Versus Biodentine in Primary Teeth Pulpotomy: Clinical And Radiographic Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05812053
• Other study ID #: #R-PED-9-20-2
• Status: Recruiting
• Phase: N/A
• 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
• 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. Biodentine™ (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.

Related Conditions & MeSH terms

• Dental Pulp Exposure
• Pulp Exposure, Dental
• Pulpitis

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