Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-10 @ 6:02 AM
Study NCT ID:
NCT06043258
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2023-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bond Apatite in Horizontal Augmentation Versus Bio-Oss
Sponsor:
Mansoura University
Organization:
Study Overview
Official Title:
Clinical and Radiographic Assessment of Bond Apatite in Horizontal Bone Augmentation Around Dental Implant
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BondApatite
Brief 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. 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:
1. 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.
2. 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).
3. 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.
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:
1. 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.
2. 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).
3. 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: