Osteogenic Potential of Cissus Quadrangularis Alveolar Ridge Distraction

Dental Implant Clinical Trial

Official title:

Evaluation of Osteogenic Potential of Cissus Quadrangularis on Mandibular Alveolar Ridge Distraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04669795
• Other study ID #: Al-AlAzhar University
• Status: Completed
• Phase: Phase 2
• Start date: April 15, 2017
• Est. completion date: August 15, 2019

Study information

• Verified date: December 2020
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Deficient alveolar mandibular ridge corrected distraction osteogenesis to facilitate dental implant placement. Patients grouped into 2 groups: one group received Cissus quadrangularis during the consolidation period, and the other group received placebo.

Description:

OPGs were taken immediately after distractor placement, at end of activation period, at 1st,2nd month of consolidation period, and at end of consolidation period. Change in bone height was evaluated immediately after distractor placement, at end of activation and end of consolidation periods. CBCT were taken immediately after implant installation, and 6 months later to evaluate change bone density and marginal bone level about the dental implant. histological evaluation was done by biopsy obtained, by trephine bur, from implant site during its preparation. The bone biopsy fixed in 4% formalin solution for 7 days, rinsed in water, and dehydrated in sequent phases of ethanol (70, 80, 90, and 100%) and then specimens were stained by hematoxylin- eosin for microscopic evaluation. Radiographic evaluation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 15, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

Inclusion Criteria:

• Patients were included if they were free from any disease that may affect healing. Also, presented with 2-3 missing teeth at least in posterior area and CBCT showed bone height above inferior alveolar canal (IAC) ranged 8-10mm.

Exclusion Criteria:

• patients were excluded if they suffered from any disease affect tissue healing, bad oral hygiene or heavy smoking patients

Related Conditions & MeSH terms

• Dental Implant
• Distraction of Bone

Intervention

Drug:
• Cissus Quadrangularis
Drug with osteogenic potential given to the patients after consolidation period. dose was two capsules once /day with meals for 6 weeks

Locations

Country	Name	City	State
Egypt	Faculty of dental medicine	Cairo	Nasr City

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone gain after distraction	Increase in bone height after distraction	immediately at end of distractor activation
Primary	Relapse after distraction	Relapse evaluated on panorama	3 months from beginning of consolidation period
Primary	Crestal bone loss around dental implant	By using cone beam CT, crestal bone level around implant evaluated by measuring a distance from implant apex to a point on dental implant where bone contacts the dental implant mesially and distally. then average of bone loss round each implant was obtained.	6 months from implant placement
Primary	Bone density around dental implant	By using cone beam CT, bone density assessed around dental implant at crestal, middle, and apical portions then average was obtained	6 months from implant placement