Osteogenic Potential of Cissus Quadrangularis Alveolar Ridge Distraction

Study Overview
=================
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

Official Title
-----------------
Evaluation of Osteogenic Potential of Cissus Quadrangularis on Mandibular Alveolar Ridge Distraction

Conditions
-----------------
Distraction of Bone, Dental Implant

Intervention / Treatment
-----------------
* Drug: Cissus Quadrangularis


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>Placebo was given to ten patients during consolidation period ( 2 capsule daily for 6 months during consolidation period) | Drug: Cissus Quadrangularis<br>* Drug with osteogenic potential given to the patients after consolidation period. dose was two capsules once /day with meals for 6 weeks<br>* Other names: Hadiod capsule;|
| Experimental: Group 2<br>Cissus quadrangularis in form of capsules given to ten patients ( 2 capsule daily for 6 months during consolidation period) | Drug: Cissus Quadrangularis<br>* Drug with osteogenic potential given to the patients after consolidation period. dose was two capsules once /day with meals for 6 weeks<br>* Other names: Hadiod capsule;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone gain after distraction | Increase in bone height after distraction | immediately at end of distractor activation | 
| Relapse after distraction | Relapse evaluated on panorama | 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. | 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 | 6 months from implant placement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alveolar, Bone, Distraction