Distraction of BonePhase 2NCT04669795
Osteogenic Potential of Cissus Quadrangularis Alveolar Ridge Distraction
A Phase 2 study testing Cissus Quadrangularis in people with Distraction of Bone and Dental Implant, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Distraction of Bone, Dental Implant
- What is being tested?
- Cissus Quadrangularis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2017to 15 Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- patients were excluded if they suffered from any disease affect tissue healing, bad oral hygiene or heavy smoking patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Distraction of Bone, Dental Implant
- Being tested
- Cissus Quadrangularis
- Keywords
- Alveolar, Bone, Distraction
- Medical subject headings
- Diastasis, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cissus QuadrangularisDrug
Also called Hadiod capsule
Drug with osteogenic potential given to the patients after consolidation period. dose was two capsules once /day with meals for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Placebo was given to ten patients during consolidation period ( 2 capsule daily for 6 months during consolidation period) Receives: 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) Receives: Drug: Cissus Quadrangularis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone gain after distraction
Increase in bone height after distraction
Measured: immediately at end of distractor activation
Relapse after distraction
Relapse evaluated on panorama
Measured: 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.
Measured: 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
Measured: 6 months from implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start15 Apr 2017
- Primary completion30 May 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distraction of BoneStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Altaweel, Al-Azhar University
- Investigators
- Altaweel, Principal investigator, Al-Alharby university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669795
- Sponsor's protocol ID
- Al-AlAzhar University
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34607598
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Osteogenic Potential of Cissus Quadrangularis on Mandibular Alveolar Ridge Distraction
- ClinicalTrials.gov ID
- NCT04669795
- Acronym / sponsor ID
- Al-AlAzhar University
- Conditions
- Distraction of Bone, Dental Implant
- Keywords
- Alveolar, Bone, Distraction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Drug: Cissus QuadrangularisPlacebo was given to ten patients during consolidation period ( 2 capsule daily for 6 months during consolidation period) |
| Group 2 | Experimental | Drug: Cissus QuadrangularisCissus quadrangularis in form of capsules given to ten patients ( 2 capsule daily for 6 months during consolidation period) |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- patients were excluded if they suffered from any disease affect tissue healing, bad oral hygiene or heavy smoking patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cissus QuadrangularisAlso: Hadiod capsuleDrug with osteogenic potential given to the patients after consolidation period. dose was two capsules once /day with meals for 6 weeks | Drug | Group 1, Group 2 |
Primary outcome
Bone gain after distraction
Time frame: immediately at end of distractor activation
Increase in bone height after distraction
Relapse after distraction
Time frame: 3 months from beginning of consolidation period
Relapse evaluated on panorama
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Derived from this study: PubMed 34607598Altaweel 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.
- Individual participant dataSharing planned: No
Related trials for Distraction of Bone
Enrolling by invitation
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Bone Marrow Aspiration, Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Altaweel principal investigator
Al-Alharby university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cissus Quadrangularis in people with Distraction of Bone and Dental Implant, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone gain after distraction (time frame: immediately at end of distractor activation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04669795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.