Efficacy of Synthetic Bone Graft for Treatment of Peri-implantitis

Peri-Implantitis Clinical Trial

Official title:

Clinical Efficacy of Easy-graft CLASSIC for the Treatment of Peri-implantitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03213210
• Other study ID #: CLP-2017-02-18-1
• Status: Terminated
• Phase: N/A
• Start date: November 12, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2021
• Source: Sunstar Americas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single arm study to evaluate the effectiveness of treatment approach using a new moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in peri-implantitis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Subject has read and signed the Institutional Review Board approved consent form before treatment.

• Subject must be age 21 or above.

• Subject must be willing and able to follow study procedures and instructions.

• Subject affected by moderate to severe peri-implant disease.

• Treated chronic periodontitis and proper periodontal maintenance care.

• Dental implant must meet the following criteria to be selected for the study:

1. Implant presenting Probing Depth = 6 mm

2. Radiographic implant bone loss more than 25% of the implant length (Apex of the implant to implant platform) .

3. Peri implant bone defect being a buccal dehiscence and semicircular bone resorption to the middle of the implant body, buccal dehiscence and circular bone resorption with lingual bone plate intact or circular bone resorption with buccal and lingual bone plates intact

4. Single tooth implant restoration or implant supported fixed partial denture.

Exclusion Criteria:

• Subjects participating (currently or within 30 days prior to enrollment) in other clinical trials involving therapeutic intervention (either medical or dental).

• Subjects with poor oral hygiene as indicated by a score of greater than 50% on the O'Leary Plaque Index.

• Subjects with a systemic condition, which would preclude periodontal treatment, including but not limited to uncontrolled diabetes.

• Subjects with acute infectious lesions in the areas intended for treatment.

• Subjects taking chronic (i.e., > 2 weeks), therapeutic doses of medications known to affect bone metabolism such as nonsteroidal anti-inflammatory drugs or bisphosphonates. Prophylactic aspirin (= 325 mg q.d.) for cardiovascular indications will be permitted in subjects.

• Female subjects who are pregnant or lactating, or sexually-active female subjects who are of childbearing potential and are not using hormonal or barrier methods of birth control. (except for when a result of pregnancy test is negative)

• Subjects who are on any chronic antibiotic or steroidal therapy.

• Smoker using more than 10 cigarettes or equivalent per day.

• Smoker using cigar, smokeless tobacco use or e-cigarette.

• Subjects diagnosed with drug induced gingival hyperplasia (e.g. calcium channel blockers).

• Subjects with radiographic evidence of pathology in other areas of the mouth besides implant area to be treated.

• Implant mobility.

• Subjects with parafunctional habits and not wearing bite guard.

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Device:
• easy-graft CLASSIC (beta-Tricalcium Phosphate)
easy-graft will be grafted to the bone defect supporting a dental implant and covered by polylactide membrane to facilitate regeneration of new bone and healthy attachment to stabilize the dental implant.

Locations

Country	Name	City	State
United States	Creighton University School of Dentisty	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Sunstar Americas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Probing Depth	Distance of probe penetration from gingival margin to bottom of peri-implant pocket	Change from baseline at 12 months after the surgery
Primary	Esthetic Satisfaction	To be assessed by examiner and subject using the Visual Analog Scales	At 12 months after the surgery
Secondary	Change of Marginal Bone Level	Change of marginal bone level on periapical standardized radiographs from baseline.	Change from baseline at 6 and 12 months after the surgery
Secondary	Change in Width of Keratinized Tissue	Distance between free gingival margin and mucogingival junction	Change from baseline at 6 and 12 months after the surgery
Secondary	Change in Clinical Attachment Level	Distance of probe penetration from fixed reference to bottom of peri-implant	Change from baseline to at 6 and 12 months after the surgery