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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04669795
Other study ID # Al-AlAzhar University
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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