Osteogenic Potential of Cissus Quadrangularis Alveolar Ridge Distraction

Phase 2

Completed

• Conditions: Distraction of Bone; Dental Implant
• Interventions: Drug: Cissus Quadrangularis

• Registration Number: NCT04669795
• Lead Sponsor: Al-Azhar University

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2017-04-15
• Primary Completion: 2019-05-30
• Study Completion: 2019-08-15
• Status Verified: 2020-12
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-09
• Last Update Submitted: 2020-12-09
• Study First Posted: 2020-12-17
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Cissus Quadrangularis	Placebo was given to ten patients during consolidation period ( 2 capsule daily for 6 months during consolidation period)
Group 2	Cissus Quadrangularis	Cissus quadrangularis in form of capsules given to ten patients ( 2 capsule daily for 6 months during consolidation period)

Primary Outcome Measures

Name	Time	Method
Relapse after distraction	3 months from beginning of consolidation period	Relapse evaluated on panorama
Bone gain after distraction	immediately at end of distractor activation	Increase in bone height after distraction
Crestal bone loss around dental implant	6 months from implant placement	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.
Bone density around dental implant	6 months from implant placement	By using cone beam CT, bone density assessed around dental implant at crestal, middle, and apical portions then average was obtained

Trial Locations

Locations (1)

Faculty of dental medicine; 🇪🇬 Cairo, Nasr City, Egypt