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

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: Healing Wound
• Intervention / Treatment: Drug: ziziphus honey

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

Collaborators and Investigators

• Sponsor: Postgraduate Medical Institute, Lahore
• Investigators: Principal Investigator: Momina Khalid, BDS, PGMI, Lahore

Publications and helpful links

General 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.

Helpful Links

• bone healing assessed through BMP-2 and OPN

Study record dates

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