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OpenTrials
Completed

NCT Number: NCT06043258

Bond Apatite in Horizontal Augmentation Versus Bio-Oss

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohammed Farrag

Damietta, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bond Apatite

Other

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

Bio-Oss

Other

xenograft bone substitute

Primary outcomes

  1. Bone width gain measurement

    Time frame: 12 months

    CBCT used to assess horizontal bone measurement.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: BondApatite

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 21, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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