Socket Preservation - A Randomized Clinical Implementation in a Student Setting
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSigmund Freud PrivatUniversitat
About this trial
Preserving the ridge dimension after tooth extraction aims to avoid the need for bone augmentation procedures before implant placement. This study aims to show that socket preservation procedure is a safe, easy and predictable method that stabilizes the bone situation when late implantation is planned.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Study participants have signed patient information and consent form
Age between 18-65 years, all genders included
Study participants who are considering a planned extraction of a mandibular posterior tooth with subsequent treatment with an implant
Study participants with medical and anatomical conditions that correspond to the applicable instructions for use
Disqualifiers
Study participants under 18 years of age
Study participants with allergies or undesirable reactions to the materials used - Patients with uncontrolled diabetes mellitus (HbA1C value >8%)
Heavy smokers (>10 cigs/day)
Previous general medical conditions that influence bone metabolism (Bone metabolic diseases such as osteopetrosis, osteomalacia, Paget's disease, metabolic diseases such as hyperthyroidism, renal osteopathy, oophorectomy, uncontrolled diabetes mellitus type 2), malignant neoplasms, chemotherapy/radiation therapy in the head and neck area and immunocompromised patients)
Trial design
Design model
Parallel
Treatments tested in this trial
Socket Preservation
Procedure/SurgeryAfter extracting a tooth, the alveolar socket is cleaned. A bone replacement material (Bio-Oss Collagen) is then placed into the socket and sutured with a collagen membrane (Mucograft-Seal). Patients will receive Antibiotics (Augmentin 875mg/125mg OR Dalacin C 300mg) and pain medication (Seractil forte 400 mg). Patients will be advised to carefully rinse with Chlorhexamed forte for one week. Sutures will be removed after two weeks.
Treatment groups
51 Participants
are divided into 3 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Socket Preservation - StudentActive comparator 1 intervention
Group C: Socket Preservation - surgeonActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
three-dimensional bone changes
horizontal bone dimension changes
Time frame
measured after six months after extraction2
three-dimensional bone changes
vertical bone dimension changes
Time frame
measured after six monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: