Clinical trial NCT05025306: Healing Effect of Ziziphus Honey on Extracted Tooth Socket in Humans by Evaluating the Levels of BMP-2 and OPN
Official title: Healing Effect of Ziziphus Honey on Extracted Tooth Socket in Humans by Evaluating the Levels of BMP-2 and OPN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healing Wound
Lead sponsor: Postgraduate Medical Institute, Lahore
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial with simple random sampling technique
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: levels of BMP-2
timeFrame: 1 week
measure: levels of OPN
timeFrame: 1 week
measure: Relative bone density
timeFrame: 40 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Post graduate medical institute, Lahore
state: Punjab
Study officials:
affiliation: PGMI, Lahore
name: Momina Khalid, BDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.