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

December 3, 2021 updated by: Anas Rahima, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sherine Badr Youness, Associate Prof
  • Phone Number: 01001408341

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Active Comparator: 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.
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.
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound healing size in length and width
Time Frame: After one week will be calculated the size (lentgh and width) of socket

There is only one outcome (wound healing)

• Multiple measurements (Digital caliper, color, palpation, presence of pus, gingival margin status).

  1. Digital caliper: a device used to calculate the size of the socket (width and length) buccolingual in mesiodistal with measurement of mm.
  2. Color: normal (pinkish gingiva) Up normal (reddish gingiva)
  3. Palpation: if there is bleeding or not.
  4. Presence of pus: yes or no
  5. Gingival margin: epithelization (yes or no)
After one week will be calculated the size (lentgh and width) of socket

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 22, 2022

Primary Completion (Anticipated)

September 4, 2023

Study Completion (Anticipated)

September 4, 2023

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

December 3, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Actual)

December 17, 2021

Last Update Submitted That Met QC Criteria

December 3, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wound healing on pediatric

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wound Heal

Clinical Trials on Hyaluronic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe