Clinical trial NCT06539299: Socket Preservation - A Randomized Clinical Implementation in a Student Setting
Official title: Socket Preservation - How Successful is the Method for Inexperienced Practitioners? A Randomized Clinical Implementation in a Student Setting
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alveolar Bone Loss
Dental Implant
Bone Augmentation
Lead sponsor: Sigmund Freud PrivatUniversitat
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Preserving the ridge dimension after tooth extraction aims to avoid the need for further augmentative procedures before implant placement. Immediately after the extraction a bone replacement material is inserted into the empty socket and covered with a membrane to protect it to maintain or even improve alveolar bone dimension. But how promising is it, if such an operation is carried out by an inexperienced practitioner? The aim is to show that socket preservation is a predictable, promising and an easy-to-implement method that creates a better initial bone situation for later implant placement. The execution by a student is intended as a simulation of a inexperienced practitioners.

Design:

A total of 51 patients with the need of extraction of a single-rooted lower jaw tooth (35-45) will be recruited from the dental clinic of the Sigmund Freud Private University. Written consent will be given before enrollment in the study. All subjects will receive a professional cleaning and hygiene instruction before the start of the study. The extracted tooth will be replaced by a dental implant after six months of healing.

The patients are divided into three groups (17 participants each).

Group 1 serves as a control group, no ridge prophylactic measures are taken after tooth extraction.

In groups 2 and 3 after the extraction, a socket preservation is made with a company's bone replacement material and a membrane (Geistlich (BioOss Collagen + Mucograft Seal)) by a student (Group 2) or investigator doctor (3. The allocation to the respective group is carried out randomly using a random generator. The entire treatment takes place in all groups under the supervision of one study doctor.

Dimensional changes of the bone will be measured after the extraction and after 6 month using CBCT Scans.

Eligibility criteria: Inclusion Criteria:

* 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
* Study participants agree to student treatment

Exclusion Criteria:

* 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)
* which can be determined clinically or radiologically pathological symptoms in the oral cavity or on the alveolar processes or the adjacent regions, untreated acute or chronic disease of the periodontium, untreated disease of the oral mucosa - drug abuse, alcohol disease or abuse

Primary outcomes:
measure: three-dimensional bone changes
timeFrame: measured after six months after extraction
measure: three-dimensional bone changes
timeFrame: measured after six months
Secondary outcomes:
Other outcomes:
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Study officials:
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