Osteogenic Potential of Cissus Quadrangularis Alveolar Ridge Distraction

NCT04669795 | Completed Phase 2

• 1 other identifier: Al-AlAzhar University
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Distraction of Bone; Dental Implant

Keywords

Alveolar; Bone; Distraction

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group 1

PLACEBO COMPARATOR

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

Drug: Cissus Quadrangularis

Group 2

EXPERIMENTAL

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

Drug: Cissus Quadrangularis

Interventions

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

Also known as: Hadiod capsule

Group 1; Group 2

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• patients were excluded if they suffered from any disease affect tissue healing, bad oral hygiene or heavy smoking patients

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of dental medicine

Cairo, Nasr City, 11651, Egypt

Location

Related Publications (1)

• 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.

  PMID: 34607598 DERIVED

MeSH Terms

Conditions

Diastasis, Bone

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Officials

• Altaweel

  Al-Alharby university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 17, 2020
• Study Start: April 15, 2017
• Primary Completion: May 30, 2019
• Study Completion: August 15, 2019
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)