Osteogenic Potential of Cissus Quadrangularis Alveolar Ridge Distraction

Evaluation of Osteogenic Potential of Cissus Quadrangularis on Mandibular Alveolar Ridge Distraction

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant; Distraction of Bone
• Intervention / Treatment: Drug: Cissus Quadrangularis

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Nasr City
    • Cairo, Nasr City, Egypt, 11651
      • Faculty of dental medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Altaweel, Al-Alharby university

Publications and helpful links

General Publications

• Altaweel AA, Baiomy AABA, Shoshan HS, Abbas H, Abdel-Hafiz AA, Gaber AE, Zewail AA, Elshiekh MAM. Evaluation of osteogenic potential of Cissus quadrangularis on mandibular alveolar ridge distraction. BMC Oral Health. 2021 Oct 4;21(1):491. doi: 10.1186/s12903-021-01847-y.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2017
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): August 15, 2019

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Bone; Distraction; Alveolar
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Diastasis, Bone
• Other Study ID Numbers: Al-AlAzhar University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No