3D Scaffold Matrix, a Class C Medical Device Bone Void Filler in Implant Dentistry
- Conditions
- Health Condition 1: K081- Complete loss of teeth
- Registration Number
- CTRI/2023/10/058842
- Lead Sponsor
- EffecMed Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1) Patients between the age of 18 and 65 years (both inclusive) requiring treatment of oral, maxillofacial and dental intraosseous defects, such as
a) single or two tooth extraction in mandibular or maxillary incisor or pre-molar region.
b) dental implant is indicated and treatment planned to replace the missing tooth(s).
c) have adequate restorative space for a dental implant-retained restoration.
d) to refill a local bony defect due to trauma or infection.
e) to refill a peri-implant defect due to peri implantitis.
f) for horizontal or vertical augmentation of the mandible and maxilla.
g) have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50 percent of the total depth of the socket.
2) Are non-smokers or former smokers. Current smokers may be included if they smoke less than 10 cigarettes per day.
3) Written informed consent obtained before any study related activities.
4) Communicative ability to understand the procedure and participate in the study and comply with the follow up.
1) Has any known diseases (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of enrolment.
2) Pregnant female or lactating or of childbearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence.
3) On chronic treatment (i.e. two weeks or more) with any medication known to affect oral status (e.g. phenytoin, dihydropyridine calcium antagonists, cyclosporine, and non-steroidal anti-inflammatory drugs) within one month of implantation.
4) On concomitant anticoagulant therapy of warfarin (coumadin), clopidogrel, ticlopidine or once daily aspirin of more than 81 mg.
5) Taking any medication or supplement known to largely influence bone metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or chronic intake of glucocorticoids.
6) Positive for HIV 1 or 2, Hepatitis B, or Hepatitis C.
7) Clinically significant thyroid stimulating hormone (1.5 times of upper limit of normal)
8) Contraindications in performing a CBCT scan.
9) Oral malignancy.
10) Uncontrolled diabetes mellitus.
11) On immunosuppressive medications.
12) Physical handicaps that would interfere with the ability to perform adequate oral hygiene.
13) Has undergone administration of any investigational drug within 30 days of study initiation.
14) Alcoholism or chronically drug abuse.
15) Heavy smoker (10/cigarettes or more per day).
16) Suffering from a known psychological disorder.
17) Has limited mental capacity or language skills such that study information cannot be understood, informed consent cannot be obtained, or simple instructions cannot be followed.
Local Exclusion Criteria
1) Mandibular incisors
2) Inadequate bone dimensions or restorative space for a dental implant
3) Uncontrolled or untreated periodontal disease
4) Bone defects that exclude implant restoration
5) Patient who has a full mouth plaque level >30 % at the enrolment visit
6) Mucosal diseases such as erosive lichen planus.
7) History of local radiation therapy
8) Presence of oral lesions (such as ulceration, malignancy)
9) Severe bruxing or clenching habits
10) Persistent intraoral infection.
11) Past radiation therapy to the surgical site.
12) Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease
13) Patient presents an acute endodontic lesion in the test tooth or in the neighbouring areas to the experimental procedure (sites with presence of an asymptomatic chronic lesion are eligible).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To analyse healing (bone growth) or recovery (device performance) of alveolar ridge vertical change (amount of bone filling in mm) and radiolucency, assessed with 2-D images of dental RVG and bone volume reconstructed with CBCT. <br/ ><br> <br/ ><br>An efficacy Endpoint Assessment and Adjudication Group independent of the study will assess alveolar ridge augmentation.Timepoint: RVG at Screening, and Week 1, Month 1, and 4. <br/ ><br>CBCT at Screening, and end of Month 1, and 4.
- Secondary Outcome Measures
Name Time Method a)Visual Analog Scale for Pain following tooth extraction and alveolar ridge preservation. <br/ ><br>b)Oral Health-Related Quality of Life (Oral Health Impact Profile-5) <br/ ><br>c)Laboratory investigations <br/ ><br>d)Incidence of (number and description) adverse events, device complaints and device-related incidents. <br/ ><br>e)Secondary intervention (surgical or nonsurgical) - Proportion of subjects not having secondary intervention conducted specifically to promote bone healing. <br/ ><br>f)Surgical site infection: Proportion of subjects having surgical site infection from the day of intervention through the study period. <br/ ><br>g)Visual Analog Scale for Investigator’s Satisfaction with the Product: Satisfaction with product assessed by the Investigator post-operativelyTimepoint: At all time points