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OpenTrials
Completed

NCT Number: NCT04669795

Osteogenic Potential of Cissus Quadrangularis 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.

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Key information

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of dental medicine

Cairo, Nasr City, 11651, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cissus Quadrangularis

Drug

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 17, 2020
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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