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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05161403
Other study ID # wound healing on pediatric
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 22, 2022
Est. completion date September 4, 2023

Study information

Verified date November 2021
Source Cairo University
Contact Anas M.gassan Raima, master's
Phone 01017562309
Email anasrahima@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the effect of hyaluronic acid and honey compared to saline in healing of multiple extraction sockets of primary teeth in a group of children aging from Two to Seven years old.


Description:

A dental extraction is one of the most unpleasant experiences in children, especially for those who have undergone traumatic experiences, and this is likely to reduce future visits to the dental clinic if the treatment is not managed properly. Alveolar osteitis is one of the most common complications following dental extraction. It is considered one of the most studied complications in dentistry, and many risk factors contribute to its occurrence including being a female, young age, tobacco use, difficult or traumatic extractions, pre-existing infection, and use of vasoconstrictor in local anesthesia. Alveolar osteitis occurs during the first three days following the day of extraction, so that the socket is devoid of the blood clot, resulting in the exposure of the bare alveolar bone. Many medicines were and are still used in treating wounds, but they are somewhat expensive.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 39
Est. completion date September 4, 2023
Est. primary completion date September 4, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 7 Years
Eligibility Inclusion Criteria: - • Age: from Two to Seven years old age. - Both genders. - Children with badly decayed multiple primary teeth beyond repair. - Treated under general anesthesia. Exclusion Criteria: - • History of systemic disease. - Allergy to honey. - Repeatedly used honey during the previous 6 month period.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Hyaluronic acid
Wound healing is still a clinical challenge especially in patients who undergo several tooth extractions under general anesthesia or those undergoing major surgeries or those with systemic conditions that disrupt the wound healing process. use of this natural substance is a simple and cost-effective technique and is easily tolerated by children.
Dietary Supplement:
honey
Wound healing is still a clinical challenge especially in patients who undergo several tooth extractions under general anesthesia or those undergoing major surgeries or those with systemic conditions that disrupt the wound healing process. Use of this natural substance is a simple and cost-effective technique and is easily tolerated by children.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

References & Publications (5)

Iacopetti I, Perazzi A, Martinello T, Gemignani F, Patruno M. Hyaluronic acid, Manuka honey and Acemannan gel: Wound-specific applications for skin lesions. Res Vet Sci. 2020 Apr;129:82-89. doi: 10.1016/j.rvsc.2020.01.009. Epub 2020 Jan 11. — View Citation

Jaffe HW, Sweeney HM, Weinstein RA, Kabins SA, Nathan C, Cohen S. Structural and phenotypic varieties of gentamicin resistance plasmids in hospital strains of Staphylococcus aureus and coagulase-negative staphylococci. Antimicrob Agents Chemother. 1982 Ma — View Citation

Maria de Souza G, Elias GM, Pereira de Andrade PF, Andrade Sales KN, Galvão EL, Moreira Falci SG. The Effectiveness of Hyaluronic Acid in Controlling Pain, Edema, and Trismus After Extraction of Third Molars: Systematic Review and Meta-Analysis. J Oral Ma — View Citation

Mokhtari S, Sanati I, Abdolahy S, Hosseini Z. Evaluation of the effect of honey on the healing of tooth extraction wounds in 4- to 9-year-old children. Niger J Clin Pract. 2019 Oct;22(10):1328-1334. doi: 10.4103/njcp.njcp_102_19. — View Citation

Naaman R, El-Housseiny AA, Alamoudi N, Helal N, Sahhaf R. Reliability and Validity of the Arabic Version of a Questionnaire Assessing Pain, Discomfort and Related Jaw Function Impairment after Extraction of Primary Teeth in Children. Dent J (Basel). 2020 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Wound healing size in length and width There is only one outcome (wound healing)
• Multiple measurements (Digital caliper, color, palpation, presence of pus, gingival margin status).
Digital caliper: a device used to calculate the size of the socket (width and length) buccolingual in mesiodistal with measurement of mm.
Color: normal (pinkish gingiva) Up normal (reddish gingiva)
Palpation: if there is bleeding or not.
Presence of pus: yes or no
Gingival margin: epithelization (yes or no)
After one week will be calculated the size (lentgh and width) of socket
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