Wound HealNCT05161403
The Efficacy of Hyaluronic Acid and Honey in Healing of Multiple Extraction Sockets of Primary Teeth Compared to Saline
A study testing Hyaluronic acid and honey in people with Wound Heal, run by Cairo University.
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. Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- Hyaluronic acid and honey
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2022to 4 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Age: from Two to Seven years old age.
- Both genders.
- Children with badly decayed multiple primary teeth beyond repair.
- Treated under general anesthesia.
Who cannot join
- • History of systemic disease.
- Allergy to honey.
- Repeatedly used honey during the previous 6 month period.
Trial locations and contacts
No sites are listed yet.
Sherine Badr Youness, Associate Prof contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Wound Heal
- Being tested
- Hyaluronic acid, honey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDrug
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.
honeyDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid. | Active comparator | 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. Receives: Drug: Hyaluronic acid; Dietary Supplement: honey |
| Honey | Active comparator | 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. Receives: Drug: Hyaluronic acid; Dietary Supplement: honey |
| Saline | Placebo comparator | 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. Receives: Drug: Hyaluronic acid; Dietary Supplement: honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: After one week will be calculated the size (lentgh and width) of socket
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start22 Feb 2022 (estimated)
- Primary completion4 Sep 2023 (estimated)
- Study completion4 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anas Rahima, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161403
- Sponsor's protocol ID
- wound healing on pediatric
- Status last verified
- Nov 2021
- First submitted
- 26 Oct 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33086538Iacopetti 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.
PubMed 31954318Maria 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.
PubMed 32771444Mokhtari 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.
PubMed 31607720Jaffe 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.
PubMed 7103456
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05161403
- Acronym / sponsor ID
- wound healing on pediatric
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Feb 2022 (estimated)
- Primary completion
- 4 Sep 2023 (estimated)
- Study completion
- 4 Sep 2023 (estimated)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid. | Active comparator | Drug: Hyaluronic acid, Dietary Supplement: honey1mm 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. |
| Honey | Active comparator | Drug: Hyaluronic acid, Dietary Supplement: honey1mm 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. |
| Saline | Placebo comparator | Drug: Hyaluronic acid, Dietary Supplement: honeya 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. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Age: from Two to Seven years old age.
Key exclusion criteria (3 listed)
- • History of systemic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acidWound 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. | Drug | Honey, Hyaluronic acid., Saline |
| honeyWound 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, Hyaluronic acid., Saline |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Results publication: PubMed 33086538Naaman 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.
- Results publication: PubMed 31954318Iacopetti 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.
- Results publication: PubMed 32771444Maria 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.
- Results publication: PubMed 31607720Mokhtari 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.
- Results publication: PubMed 7103456Jaffe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherine Badr Youness, Associate Prof contact
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid and honey in people with Wound Heal, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anas M.gassan Raima, master's (01017562309, anasrahima@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing size in length and width (time frame: After one week will be calculated the size (lentgh and width) of socket). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05161403, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.