The Efficacy of Hyaluronic Acid and Honey in Healing of Multiple Extraction Sockets of Primary Teeth Compared to Saline

NCT ID: NCT05161403

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-22

Study Completion Date

2023-09-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Wound Heal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Clinical Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Neither the operator nor the patients could be blinded due to the nature of the study, but the statistician will be blinded.

Study Groups

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Hyaluronic acid.

1mm layer of hyaluronic acid on a piece of gauze will be applied directly to the sockets wound for 45 minutes at baseline and on the third \& seventh day after extraction of teeth.

Group Type ACTIVE_COMPARATOR

Hyaluronic acid

Intervention Type DRUG

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.

honey

Intervention Type DIETARY_SUPPLEMENT

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.

Honey

1mm layer of Honey on a piece of gauze will be applied directly to the sockets wound for 45 minutes at baseline and on the third \& seventh day after extraction of teeth.

Group Type ACTIVE_COMPARATOR

Hyaluronic acid

Intervention Type DRUG

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.

honey

Intervention Type DIETARY_SUPPLEMENT

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.

Saline

a piece of gauze moistened with normal saline will be applied directly to the sockets wound for 45 minutes at baseline and on the third \& seventh day after extraction of teeth.

Group Type PLACEBO_COMPARATOR

Hyaluronic acid

Intervention Type DRUG

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.

honey

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Anas Rahima

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Anas M.gassan Raima, master's

Role: CONTACT

Phone: 01017562309

Email: [email protected]

Sherine Badr Youness, Associate Prof

Role: CONTACT

Phone: 01001408341

References

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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 Oct 19;8(4):120. doi: 10.3390/dj8040120.

Reference Type RESULT
PMID: 33086538 (View on PubMed)

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.

Reference Type RESULT
PMID: 31954318 (View on PubMed)

Maria de Souza G, Elias GM, Pereira de Andrade PF, Andrade Sales KN, Galvao 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 Maxillofac Surg. 2020 Dec;78(12):2154.e1-2154.e12. doi: 10.1016/j.joms.2020.07.005. Epub 2020 Jul 14.

Reference Type RESULT
PMID: 32771444 (View on PubMed)

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.

Reference Type RESULT
PMID: 31607720 (View on PubMed)

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 May;21(5):773-9. doi: 10.1128/AAC.21.5.773.

Reference Type RESULT
PMID: 7103456 (View on PubMed)

Other Identifiers

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wound healing on pediatric

Identifier Type: -

Identifier Source: org_study_id