A Phase 2 interventional study of Cissus Quadrangularis in Distraction of Bone and Dental Implant, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Al-Azhar University · Phase 2, Interventional, and Treatment
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.
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
Exclusion Criteria:
Placebo was given to ten patients during consolidation period ( 2 capsule daily for 6 months during consolidation period)
Drug: Cissus Quadrangularis
Cissus quadrangularis in form of capsules given to ten patients ( 2 capsule daily for 6 months during consolidation period)
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
Also known as: Hadiod capsule
Bone gain after distraction
Increase in bone height after distraction
Time frame: immediately at end of distractor activation
Relapse after distraction
Relapse evaluated on panorama
Time frame: 3 months from beginning of consolidation period
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.
Time frame: 6 months from implant placement
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
Time frame: 6 months from implant placement
Plan to share: No
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Diastasis, Bone
Al-Azhar University