Bond Apatite in Horizontal Augmentation Versus Bio-Oss

NCT06043258 | Completed

• 1 other identifier: M07061119
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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. 1.Modified plaque index:
2. 2.Modified gingival index:
3. 3.Probing depth:

Conditions

Horizontal Ridge Deficiency

Outcome Measures

Primary Outcomes (1)

• Bone width gain measurement

  CBCT used to assess horizontal bone measurement.

  12 months

Study Arms (2)

(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.

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.

Other: Bio-Oss

Interventions

Bond Apatite OTHER

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

(Group I) study group

Bio-Oss OTHER

xenograft bone substitute

(Group II) positive control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mohammed Farrag

Damietta, Egypt

Location

MeSH Terms

Interventions

Bio-Oss

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: October 10, 2020
• Primary Completion: May 15, 2021
• Study Completion: May 27, 2022
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

EG (1)