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Osteogenic Potential of Cissus Quadrangularis Alveolar Ridge Distraction

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ClinicalTrials.gov Identifier: NCT04669795
Recruitment Status : Completed
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Alaa Altaweel, Al-Azhar University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Distraction of Bone Dental Implant Drug: Cissus Quadrangularis Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Osteogenic Potential of Cissus Quadrangularis on Mandibular Alveolar Ridge Distraction
Actual Study Start Date : April 15, 2017
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : August 15, 2019
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Group 1
Placebo was given to ten patients during consolidation period ( 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
Other Name: Hadiod capsule
Experimental: Group 2
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
Other Name: Hadiod capsule


Outcome Measures
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Primary Outcome Measures :
  1. Bone gain after distraction [ Time Frame: immediately at end of distractor activation ]
    Increase in bone height after distraction

  2. Relapse after distraction [ Time Frame: 3 months from beginning of consolidation period ]
    Relapse evaluated on panorama

  3. Crestal bone loss around dental implant [ Time Frame: 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.

  4. Bone density around dental implant [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669795


Locations
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Egypt
Faculty of dental medicine
Cairo, Nasr City, Egypt, 11651
Sponsors and Collaborators
Al-Azhar University
Investigators
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Principal Investigator: Altaweel Al-Alharby university
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alaa Altaweel, Principle Investigator, Al-Azhar University
ClinicalTrials.gov Identifier: NCT04669795    
Other Study ID Numbers: Al-AlAzhar University
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alaa Altaweel, Al-Azhar University:
Alveolar
Bone
Distraction
Additional relevant MeSH terms:
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Diastasis, Bone
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries