ISRCTN62683103
Active, not recruiting
Phase 3
A prospective, randomized controlled trial to evaluate correction of ridge contour deficiency using OSSIX® Volumax vs Fibro-Gide.
Datum Dental0 sites65 target enrollmentOctober 18, 2022
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Dental ridge contour deficiency
- Sponsor
- Datum Dental
- Enrollment
- 65
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
An evaluation of the effects of the iMindTime Digital Health program on wellbeingDepressionAnxietyMental Health - AnxietyMental Health - DepressionACTRN12621000129886Federation University Australia350
Recruiting
Not Applicable
locking plate for treatment of intertrochanteric hip fracturesintertrochanteric hip fracturesInjuries and Accidents - FracturesACTRN12610000992000Zhao Gangsheng100
Not yet recruiting
Phase 3
Clinical trial ofstress and Sleep management supplementCTRI/2024/07/070701ife Synergy
Not yet recruiting
Phase 1
Prospective randomized controlled trial to evaluate the effect of tranexamic acid in irrigant solution on perioperative blood loss during mini-percutaneous nephrolithotomyPatients who have renal calculi and undergo mini-percutaneous nephrolithotomyTranexamic acidIrrigant solutionMini-Percutaneous nephrolithotomyPerioperative blood lossTCTR20211021003/A50
Recruiting
Not Applicable
A research study to evaluate the current management of patients with chronic heart failure with the usual care plus additional remote monitoring by study doctors and a research nurseChronic Heart FailureCardiovascular - Coronary heart diseaseCardiovascular - Other cardiovascular diseasesACTRN12609000082202Curtin University of Technology102