NCT05025306

Brief Summary

Ziziphus honey can improve bone healing at extracted tooth sockets in humans by increasing salivary levels of bone markers, OPN and BMP-2.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

August 23, 2021

Last Update Submit

August 26, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • levels of BMP-2

    bone morphogenetic protein-2 levels to access amount of bone healing

    1 week

  • levels of OPN

    Osteopontin levels to access amount of bone healing

    1 week

  • Relative bone density

    bone quality confirmed on periapical radiographs in both groups

    40 days

Study Arms (2)

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

Drug: ziziphus honey

Interventions

ziziphus honey obtained form ziziphus spina-christi trees also called sidr tree

Also known as: sidr honey, honey
experimental group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy patients of either gender with adult age
  • No known hypersensitivity to honey.
  • Permanent maxillary or mandibular molars (first or second molars)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post graduate medical institute, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 18692778BACKGROUND

Related Links

MeSH Terms

Interventions

Honey

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Momina Khalid, BDS

    PGMI, Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were not aware of the intervention used
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled trial with simple random sampling technique
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 27, 2021

Study Start

January 1, 2020

Primary Completion

March 16, 2020

Study Completion

June 1, 2020

Last Updated

September 1, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations