A prospective, randomized trial to compare correction of ridge contour deficiency (shrinking of the gum and bone) using OSSIX® Volumax or Fibro-Gide.

Phase 3

• Conditions: Dental ridge contour deficiency; Oral Health

• Registration Number: ISRCTN62683103
• Lead Sponsor: Datum Dental

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-18
• Last Update Posted: 31 October 2022
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. Males and females =18 years
2. General good health (ASA 1 and ASA 2)
3. Presence of a tissue contour deficiency leading to an unesthetic implant rehabilitation, not associated with bone dehiscence and/or fenestration defects.
4. Patients require 1-3 implants placed between two periodontally stable natural teeth.
5. Good oral hygiene (full mouth plaque index <25%)
6. Adequate control of inflammation (full mouth bleeding on probing <25%)
7. Patients that are willing to sign an informed consent and participate in the clinical study
8. Patient that are able to understand and to comply with the study related procedures such as exercising good oral hygiene and attending all follow-up examinations

Exclusion Criteria

1. Implant sites with associated alveolar bone dehiscence and/or fenestration defects that necessitate bone grafting in combination with correction of ridge contour deficiency.
2. General contraindications for dental and/or surgical treatments
3. Inflammatory and autoimmune disease of the oral cavity
4. Allergy to collagen
5. Uncontrolled diabetes (A1C > 6.5 %)
6. Disease of oral mucosa
7. Disease affecting connective tissue metabolism (e.g. collagenases)
8. Uncontrolled Periodontal disease
9. History of myeloma, respiratory tract cancer, breast cancer, prostate cancer, or kidney cancer requiring chemotherapy or radiotherapy.
10. Concurrent or previous radiotherapy of head area
11. Concurrent or previous immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy
12. Heavy Smokers (over 10 cigarettes a day)
13. Pregnant or lactating women.
14. Women of childbearing age, who are not using a highly effective method of birth control
15. Participation in another investigational device, drug, or biologics study within the last 24 weeks prior to the study start.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measuring the width of the ridge by intra oral scanner at 6 and 12 months