Healing Effect of Ziziphus Honey on Extracted Tooth Socket in Humans by Evaluating the Levels of BMP-2 and OPN

August 26, 2021 updated by: Momina khalid, Postgraduate Medical Institute, Lahore
Ziziphus honey can improve bone healing at extracted tooth sockets in humans by increasing salivary levels of bone markers, OPN and BMP-2.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Post graduate medical institute, Lahore

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of radiotherapy or chemotherapy
  2. Diabetic and hypertensive patients.
  3. Pregnant and lactating females.
  4. Smoking or consumption of alcohol
  5. Bone conditions like osteoporosis etc.
  6. Patients on oral contraceptives or steroid therapy
  7. Subjects taking antibiotics or NSAIDS within one week.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
only atraumatic extractions were done, honey was not applied
Experimental: experimental group
ziziphus honey was applied into the sockets after tooth extractions in experimental group
Drug: ziziphus honey
ziziphus honey obtained form ziziphus spina-christi trees also called sidr tree
Other Names:
  • sidr honey
  • honey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
levels of BMP-2
Time Frame: 1 week
bone morphogenetic protein-2 levels to access amount of bone healing
1 week
levels of OPN
Time Frame: 1 week
Osteopontin levels to access amount of bone healing
1 week
Relative bone density
Time Frame: 40 days
bone quality confirmed on periapical radiographs in both groups
40 days

Collaborators and Investigators

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

Sponsor

Postgraduate Medical Institute, Lahore

Investigators

  • Principal Investigator: Momina Khalid, BDS, PGMI, Lahore

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

Helpful Links

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 (Actual)

January 1, 2020

Primary Completion (Actual)

March 16, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

August 23, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 26, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • PGMILahore

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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