Bond Apatite in Horizontal Augmentation Versus Bio-Oss

NCT ID: NCT06043258

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-10
• Study Completion Date: 2022-05-27

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.

Conditions

Horizontal Ridge Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study 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 Type: EXPERIMENTAL

Bond Apatite

Intervention Type: OTHER

composite graft formed of biphasic calcium sulphate and hydroxyapatite at a ratio of 2:1

(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.

Group Type: ACTIVE_COMPARATOR

Bio-Oss

Intervention Type: OTHER

xenograft bone substitute

Interventions

Bond Apatite

composite graft formed of biphasic calcium sulphate and hydroxyapatite at a ratio of 2:1

Intervention Type: OTHER

Bio-Oss

xenograft bone substitute

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mohammed Farrag

Damietta, , Egypt

Countries

Egypt

Other Identifiers

M07061119

Identifier Type: -

Identifier Source: org_study_id