Socket Preservation - A Randomized Clinical Implementation in a Student Setting

NCT06539299 | Not Yet Recruiting

• 1 other identifier: SocketPreservationStudents
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alveolar Bone Loss; Dental Implant; Bone Augmentation

Outcome Measures

Primary Outcomes (2)

• three-dimensional bone changes

  horizontal bone dimension changes

  measured after six months after extraction

• three-dimensional bone changes

  vertical bone dimension changes

  measured after six months

Study Arms (3)

Control Group

NO INTERVENTION

No bone preservation procedure after tooth extraction

Socket Preservation - Student

ACTIVE COMPARATOR

Socket preservation done by a student

Procedure: Socket Preservation

Socket Preservation - surgeon

ACTIVE COMPARATOR

Socket preservation done by a surgeon

Procedure: Socket Preservation

Interventions

Socket Preservation PROCEDURE

After 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.

Socket Preservation - Student; Socket Preservation - surgeon

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sigmund Freud PrivatUniversitat: lead

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Katharina Georg

CONTACT

+4368181891155; katharina.georg@med.sfu.ac.at

Markus Hof

CONTACT

markus.hof@med.sfu.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: September 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share