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

Healing Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05025306
• Other study ID #: PGMILahore
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Healing Wound

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

External Links

•   bone healing assessed through BMP-2 and OPN