Bond Apatite in Horizontal Augmentation Versus Bio-Oss

Horizontal Ridge Deficiency Clinical Trial

— BondApatite  

Official title:

Clinical and Radiographic Assessment of Bond Apatite in Horizontal Bone Augmentation Around Dental Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06043258
• Other study ID #: M07061119
• Status: Completed
• Phase: N/A
• Start date: October 10, 2020
• Est. completion date: May 27, 2022

Study information

• Verified date: September 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 27, 2022
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Horizontal Ridge Deficiency

Intervention

Other:
• Bond Apatite
composite graft formed of biphasic calcium sulphate and hydroxyapatite at a ratio of 2:1
• Bio-Oss
xenograft bone substitute

Locations

Country	Name	City	State
Egypt	Mohammed Farrag	Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone width gain measurement	CBCT used to assess horizontal bone measurement.	12 months