- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06043258
Bond Apatite in Horizontal Augmentation Versus Bio-Oss (BondApatite)
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:
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:
A) 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.
B) 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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Damietta, Egypt
- Mohammed Farrag
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: (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.
|
composite graft formed of biphasic calcium sulphate and hydroxyapatite at a ratio of 2:1
|
Active Comparator: (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.
|
xenograft bone substitute
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone width gain measurement
Time Frame: 12 months
|
CBCT used to assess horizontal bone measurement.
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- M07061119
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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