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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05025306
Other study ID # PGMILahore
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 1, 2020
Est. completion date June 1, 2020

Study information

Verified date August 2021
Source Postgraduate Medical Institute, Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 1, 2020
Est. primary completion date March 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Pakistan Post graduate medical institute, Lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Postgraduate Medical Institute, Lahore

Country where clinical trial is conducted

Pakistan, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary levels of BMP-2 bone morphogenetic protein-2 levels to access amount of bone healing 1 week
Primary levels of OPN Osteopontin levels to access amount of bone healing 1 week
Primary Relative bone density bone quality confirmed on periapical radiographs in both groups 40 days
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