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

Study Overview
=================
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.

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).

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

Conditions
-----------------
Healing Wound

Intervention / Treatment
-----------------
* Drug: ziziphus honey


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial with simple random sampling technique
Masking: Single


Arms and Interventions

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