Horizontal Ridge DeficiencyBondApatiteNCT06043258
Bond Apatite in Horizontal Augmentation Versus Bio-Oss
A study testing Bond Apatite and Bio-Oss in people with Horizontal Ridge Deficiency, run by Mansoura University at 1 site in Egypt.
Trial summary
Sixteen healthy patients selected from the Outpatient Clinic of the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology, Faculty of Dentistry, Mansoura University for the replacement of missing single maxillary anterior or premolar tooth (in the esthetic zone) by dental implant. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Horizontal Ridge Deficiency
- What is being tested?
- Bond Apatite and Bio-Oss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2020to 27 May 2022
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients older than 18 years.
- Good general health.
- Able to provide informed consent.
- Availability for multiple follow up appointments.
- Every patient should have at least one missing tooth in the maxillary anterior premolar area and subsequently scheduled for implant supported prosthesis.
- The tooth has been extracted from at least 3 months.
- Insufficient horizontal bone (class III according to Len Tolstunov classification.
- Good oral hygiene.
Who cannot join
- History of systemic disease that will contraindicate intraoral surgical procedures.
- Chronic treatment with any medication known to affect oral status and bone turnover.
- Surgical procedures within 30 days of study initiation.
- Long term nonsteroidal anti-inflammatory drugs exceeding 100 mg per day.
- Pregnant or lactating women.
- Acute dentoalveolar infection
- Smokers more than 10 cigarettes per day.
- Uncontrolled or untreated periodontal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Assessment of Bond Apatite in Horizontal Bone Augmentation Around Dental Implant
Sixteen healthy patients selected from the Outpatient Clinic of the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology, Faculty of Dentistry, Mansoura University for the replacement of missing single maxillary anterior or premolar tooth (in the esthetic zone) by dental implant. Patients were selected according to the following criteria: 1) Patients older than 18 years. 2) Good general health, with no systemic diseases that might contraindicate receiving a dental implant. 3) Every patient should have at least one missing tooth in the maxillary anterior premolar area and subsequently scheduled for implant supported prosthesis. 4) The tooth has been extracted from at least 3 months. 5) Insufficient horizontal bone (class III according to Len Tolstunov classification. 6) Good oral hygiene.
Patients were classified into two groups:
Read more
Group (I) (study group): eight patients with missing anterior or premolar tooth with insufficient horizontal (bucco/labio palatal) bone width were treated with dental implants and Bond Apatite (AugmaBio, United States of America) as a bone graft material to fill the defect.
Group (II) (positive control group): eight patients with missing anterior or premolar tooth with insufficient horizontal (bucco/labio palatal) bone width were treated with dental implants and Bio-Oss (Bio-Oss, GeistlichPharmaAG, Wolhusen, Switzerland) as a bone graft material to fill the defect and pericardium resorbable membrane.
Patients were evaluated with the following clinical and radiological parameters presurgical and 12 months after operation:
- Clinical evaluation:
The following parameters were evaluated:
- Modified plaque index: This is fundamentally based on the visual detection of plaque, it ascertains the thickness of plaque along the gingival margin, namely the desirability of distinguishing clearly between severity and the location of soft debris aggregates.
- Modified gingival index: It is a method to assess the severity of gingivitis based on gingival color, contour, presence of bleeding, stippling and crevicular fluid flow. It is completely noninvasive method (only visual).
- Probing depth:
Peri-implant pocket depth was measured using plastic implant probe (contrast PA probe # CPNG22, Helmut Zepf Medizintechnik Gmbh®) after final restoration was inserted.
- Radiographic evaluation:
Bone width was assessed using CBCT 12 months after implant insertion. Bone width measurements were made on tomographic slices perpendicular to the longitudinal axis of the alveolar crest; 2 mm from the alveolar crest.
- Conditions
- Horizontal Ridge Deficiency
- Being tested
- Bond Apatite, Bio-Oss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bond ApatiteOther
composite graft formed of biphasic calcium sulphate and hydroxyapatite at a ratio of 2:1
Bio-OssOther
xenograft bone substitute
| Study group | Role | What they receive |
|---|---|---|
| (Group I) study group | Experimental | eight patients with missing anterior or premolar tooth with insufficient horizontal (bucco/labio palatal) bone width were treated with dental implants and Bond Apatite (AugmaBio, United States of America) as a bone graft material to fill the defect. Receives: Other: Bond Apatite |
| (Group II) positive control group | Active comparator | eight patients with missing anterior or premolar tooth with insufficient horizontal (bucco/labio palatal) bone width were treated with dental implants and Bio-Oss (Bio-Oss, GeistlichPharmaAG, Wolhusen, Switzerland) as a bone graft material to fill the defect and pericardium resorbable membrane. Receives: Other: Bio-Oss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone width gain measurement
CBCT used to assess horizontal bone measurement.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start10 Oct 2020
- Primary completion15 May 2021
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horizontal Ridge DeficiencyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043258
- Sponsor's protocol ID
- M07061119
- Acronym
- BondApatite
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment of Bond Apatite in Horizontal Bone Augmentation Around Dental Implant
- ClinicalTrials.gov ID
- NCT06043258
- Acronym / sponsor ID
- BondApatite / M07061119
- Conditions
- Horizontal Ridge Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 21 Sep 2023 (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.
Sixteen healthy patients selected from the Outpatient Clinic of the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology, Faculty of Dentistry, Mansoura University for the replacement of missing single maxillary anterior or premolar tooth (in the esthetic zone) by dental implant. Patients were selected according to the following criteria: 1) Patients older than 18 years. 2) Good general health, with no systemic diseases that might contraindicate receiving a dental implant. 3) Every patient should have at least one missing tooth in the maxillary anterior premolar area and subsequently scheduled for implant supported prosthesis. 4) The tooth has been extracted from at least 3 months. 5) Insufficient horizontal bone (class III according to Len Tolstunov classification. 6) Good oral hygiene.
Patients were classified into two groups:
Group (I) (study group): eight patients with missing anterior or premolar tooth with insufficient horizontal (bucco/labio palatal) bone width were treated with dental implants and Bond Apatite (AugmaBio, United States of America) as a bone graft material to fill the defect.
Group (II) (positive control group): eight patients with missing anterior or premolar tooth with insufficient horizontal (bucco/labio palatal) bone width were treated with dental implants and Bio-Oss (Bio-Oss, GeistlichPharmaAG, Wolhusen, Switzerland) as a bone graft material to fill the defect and pericardium resorbable membrane.
Patients were evaluated with the following clinical and radiological parameters presurgical and 12 months after operation:
- Clinical evaluation:
The following parameters were evaluated:
- Modified plaque index: This is fundamentally based on the visual detection of plaque, it ascertains the thickness of plaque along the gingival margin, namely the desirability of distinguishing clearly between severity and the location of soft debris aggregates.
- Modified gingival index: It is a method to assess the severity of gingivitis based on gingival color, contour, presence of bleeding, stippling and crevicular fluid flow. It is completely noninvasive method (only visual).
- Probing depth:
Peri-implant pocket depth was measured using plastic implant probe (contrast PA probe # CPNG22, Helmut Zepf Medizintechnik Gmbh®) after final restoration was inserted.
- Radiographic evaluation:
Bone width was assessed using CBCT 12 months after implant insertion. Bone width measurements were made on tomographic slices perpendicular to the longitudinal axis of the alveolar crest; 2 mm from the alveolar crest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Group I) study group | Experimental | Other: Bond Apatiteeight patients with missing anterior or premolar tooth with insufficient horizontal (bucco/labio palatal) bone width were treated with dental implants and Bond Apatite (AugmaBio, United States of America) as a bone graft material to fill the defect. |
| (Group II) positive control group | Active comparator | Other: Bio-Osseight patients with missing anterior or premolar tooth with insufficient horizontal (bucco/labio palatal) bone width were treated with dental implants and Bio-Oss (Bio-Oss, GeistlichPharmaAG, Wolhusen, Switzerland) as a bone graft material to fill the defect and pericardium resorbable membrane. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients older than 18 years.
- Good general health.
- Able to provide informed consent.
- Availability for multiple follow up appointments.
- Every patient should have at least one missing tooth in the maxillary anterior premolar area and subsequently scheduled for implant supported prosthesis.
Key exclusion criteria (8 listed)
- History of systemic disease that will contraindicate intraoral surgical procedures.
- Chronic treatment with any medication known to affect oral status and bone turnover.
- Surgical procedures within 30 days of study initiation.
- Long term nonsteroidal anti-inflammatory drugs exceeding 100 mg per day.
- Pregnant or lactating women.
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 |
|---|---|---|
| Bond Apatitecomposite graft formed of biphasic calcium sulphate and hydroxyapatite at a ratio of 2:1 | Other | (Group I) study group |
| Bio-Ossxenograft bone substitute | Other | (Group II) positive control group |
Primary outcome
Bone width gain measurement
Time frame: 12 months
CBCT used to assess horizontal bone measurement.
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 26 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bond Apatite and Bio-Oss in people with Horizontal Ridge Deficiency, run by Mansoura 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 8 inclusion and 8 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 26 Sep 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 width gain measurement (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2023.