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Completed

NCT Number: NCT05025306

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Post graduate medical institute, Lahore

Lahore, Punjab Province, 54000, Pakistan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

ziziphus honey

Drug

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

Other names: sidr honey, honey

Primary outcomes

  1. levels of BMP-2

    Time frame: 1 week

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

  2. levels of OPN

    Time frame: 1 week

    Osteopontin levels to access amount of bone healing

  3. Relative bone density

    Time frame: 40 days

    bone quality confirmed on periapical radiographs in both groups

Sponsors and collaborators

Lead sponsor

Postgraduate Medical Institute, Lahore

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2021
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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