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Osteogenic Potential of Cissus Quadrangularis Alveolar Ridge Distraction

NCT ID: NCT04669795

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-15

Study Completion Date

2019-08-15

Brief Summary

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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

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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

Conditions

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Distraction of Bone Dental Implant

Keywords

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Alveolar Bone Distraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group 1

Placebo was given to ten patients during consolidation period ( 2 capsule daily for 6 months during consolidation period)

Group Type PLACEBO_COMPARATOR

Cissus Quadrangularis

Intervention Type DRUG

Drug with osteogenic potential given to the patients after consolidation period. dose was two capsules once /day with meals for 6 weeks

Group 2

Cissus quadrangularis in form of capsules given to ten patients ( 2 capsule daily for 6 months during consolidation period)

Group Type EXPERIMENTAL

Cissus Quadrangularis

Intervention Type DRUG

Drug with osteogenic potential given to the patients after consolidation period. dose was two capsules once /day with meals for 6 weeks

Interventions

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Cissus Quadrangularis

Drug with osteogenic potential given to the patients after consolidation period. dose was two capsules once /day with meals for 6 weeks

Intervention Type DRUG

Other Intervention Names

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Hadiod capsule

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Altaweel

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Altaweel

Role: PRINCIPAL_INVESTIGATOR

Al-Alharby university

Locations

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Faculty of dental medicine

Cairo, Nasr City, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 34607598 (View on PubMed)

Other Identifiers

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Al-AlAzhar University

Identifier Type: -

Identifier Source: org_study_id