Healing WoundPhase 3NCT05025306
Healing Effect of Ziziphus Honey on Extracted Tooth Socket in Humans by Evaluating the Levels of BMP-2 and OPN
A Phase 3 study testing ziziphus honey in people with Healing Wound, run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.
Trial summary
Ziziphus honey can improve bone healing at extracted tooth sockets in humans by increasing salivary levels of bone markers, OPN and BMP-2. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healing Wound
- What is being tested?
- ziziphus honey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2020to 1 Jun 2020
- Phase
- Phase 3
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patients of either gender with adult age
- No known hypersensitivity to honey.
- Permanent maxillary or mandibular molars (first or second molars)
Who cannot join
- History of radiotherapy or chemotherapy
- Diabetic and hypertensive patients.
- Pregnant and lactating females.
- Smoking or consumption of alcohol
- Bone conditions like osteoporosis etc.
- Patients on oral contraceptives or steroid therapy
- Subjects taking antibiotics or NSAIDS within one week.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Post graduate medical institute, Lahore
Lahore, Punjab Province, 54000
About this study
Ziziphus honey can improve bone healing at extracted tooth sockets in humans by increasing salivary levels of bone markers, OPN and BMP-2.
Read the detailed description
objectives of study: To study the effects of ziziphus honey on bone healing of extracted tooth socket in humans by comparing 1) Levels of BMP-2 and OPN in experimental and control groups at different intervals and 2) By radiographically measuring RBD of extraction sockets in experimental and control groups.
Aim of study: Post extraction ridge resorption is a major concern for future tooth prosthesis or implant placement. Honey can possibly help to improve bone healing and minimize ridge resorption after extractions.
Materials and Methods: Randomized controlled trial with simple random sampling of healthy individuals will be done. Total number of 30 participants will be equally divided into experimental group and control group. After tooth extractions in both groups, ziziphus honey will be injected into extracted sockets of experimental group while control group will be left as it is. Levels of BMP-2 and OPN will be tested in saliva through ELISA technique at day 0, 3 and 7 of tooth extraction and RBD will be measured on periapical radiographs at day 3, 21 and 40 in both groups.
Keywords: Bone morphogenetic protein-2 (BMP-2), Osteopontin (OPN), Relative bone density (RBD), Enzyme linked immunosorbent assay (ELISA).
- Conditions
- Healing Wound
- Being tested
- ziziphus honey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziziphus honeyDrug
Also called sidr honey, honey
ziziphus honey obtained form ziziphus spina-christi trees also called sidr tree
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | only atraumatic extractions were done, honey was not applied |
| experimental group | Experimental | ziziphus honey was applied into the sockets after tooth extractions in experimental group Receives: Drug: ziziphus honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of BMP-2
bone morphogenetic protein-2 levels to access amount of bone healing
Measured: 1 week
levels of OPN
Osteopontin levels to access amount of bone healing
Measured: 1 week
Relative bone density
bone quality confirmed on periapical radiographs in both groups
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Jan 2020
- Primary completion16 Mar 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healing WoundStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial with simple random sampling technique
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Medical Institute, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Momina khalid, Postgraduate Medical Institute, Lahore
- Investigators
- Momina Khalid, BDS, Principal investigator, PGMI, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025306
- Sponsor's protocol ID
- PGMILahore
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mendes RM, Silva GA, Lima MF, Calliari MV, Almeida AP, Alves JB, Ferreira AJ. Sodium hyaluronate accelerates the healing process in tooth sockets of rats. Arch Oral Biol. 2008 Dec;53(12):1155-62. doi: 10.1016/j.archoralbio.2008.07.001. Epub 2008 Aug 9.
PubMed 18692778
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Effect of Ziziphus Honey on Extracted Tooth Socket in Humans by Evaluating the Levels of BMP-2 and OPN
- ClinicalTrials.gov ID
- NCT05025306
- Acronym / sponsor ID
- PGMILahore
- Conditions
- Healing Wound
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Postgraduate Medical Institute, LahoreUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 27 Aug 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.
Ziziphus honey can improve bone healing at extracted tooth sockets in humans by increasing salivary levels of bone markers, OPN and BMP-2.
Detailed description
objectives of study: To study the effects of ziziphus honey on bone healing of extracted tooth socket in humans by comparing 1) Levels of BMP-2 and OPN in experimental and control groups at different intervals and 2) By radiographically measuring RBD of extraction sockets in experimental and control groups.
Aim of study: Post extraction ridge resorption is a major concern for future tooth prosthesis or implant placement. Honey can possibly help to improve bone healing and minimize ridge resorption after extractions.
Materials and Methods: Randomized controlled trial with simple random sampling of healthy individuals will be done. Total number of 30 participants will be equally divided into experimental group and control group. After tooth extractions in both groups, ziziphus honey will be injected into extracted sockets of experimental group while control group will be left as it is. Levels of BMP-2 and OPN will be tested in saliva through ELISA technique at day 0, 3 and 7 of tooth extraction and RBD will be measured on periapical radiographs at day 3, 21 and 40 in both groups.
Keywords: Bone morphogenetic protein-2 (BMP-2), Osteopontin (OPN), Relative bone density (RBD), Enzyme linked immunosorbent assay (ELISA).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial with simple random sampling technique
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –only atraumatic extractions were done, honey was not applied |
| experimental group | Experimental | Drug: ziziphus honeyziziphus honey was applied into the sockets after tooth extractions in experimental group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy patients of either gender with adult age
- No known hypersensitivity to honey.
- Permanent maxillary or mandibular molars (first or second molars)
Key exclusion criteria (7 listed)
- History of radiotherapy or chemotherapy
- Diabetic and hypertensive patients.
- Pregnant and lactating females.
- Smoking or consumption of alcohol
- Bone conditions like osteoporosis etc.
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 |
|---|---|---|
| ziziphus honeyAlso: sidr honey, honeyziziphus honey obtained form ziziphus spina-christi trees also called sidr tree | Drug | experimental group |
Primary outcome
levels of BMP-2
Time frame: 1 week
bone morphogenetic protein-2 levels to access amount of bone healing
levels of OPN
Time frame: 1 week
Osteopontin levels to access amount of bone healing
Relative bone density
Time frame: 40 days
bone quality confirmed on periapical radiographs in both groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Background: PubMed 18692778Mendes RM, Silva GA, Lima MF, Calliari MV, Almeida AP, Alves JB, Ferreira AJ. Sodium hyaluronate accelerates the healing process in tooth sockets of rats. Arch Oral Biol. 2008 Dec;53(12):1155-62. doi: 10.1016/j.archoralbio.2008.07.001. Epub 2008 Aug 9.
- bone healing assessed through BMP-2 and OPNLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Momina Khalid, BDS principal investigator
PGMI, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ziziphus honey in people with Healing Wound, run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
levels of BMP-2 (time frame: 1 week). The study lists 3 primary outcomes in all. 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 NCT05025306, which also lists 1 linked publication.
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 1 Sep 2021.