Clinical trial NCT05812053: Comparative Evaluation of Eggshell Powder in Primary Teeth Pulpotomy
Official title: Comparative Evaluation of Eggshell Powder Versus Biodentine in Primary Teeth Pulpotomy: Clinical And Radiographic Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulpitis Reversible
Pulp Exposure, Dental
Keywords: Cone-beam computed tomography
egg shell powder
biodentine
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess \& compare clinical \& radiographic effects of Eggshell Powder, Biodentine and MTA as pulpotomy agents in primary teeth.

Detailed 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. To date, there is insufficient evidence to properly evaluate Eggshell Powder as a pulpotomy agent in primary teeth; thus, the current study aimed to assess and compare clinical and radiographical success of Eggshell Powder, Biodentine and MTA as pulpotomy agents in primary teeth.

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.

Primary outcomes:
measure: absence of pain
timeFrame: up to 12 months
measure: absence of fistula
timeFrame: up to 12 months
measure: Tenderness to percussion
timeFrame: Up to 12 month
measure: Furcation radiolucency
timeFrame: 6 months
measure: Furcation radiolucency
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: Gharbia
Study officials:
References:
citation: 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.
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.
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.
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.