NCT06539299

Socket Preservation - A Randomized Clinical Implementation in a Student Setting

Socket Preservation - How Successful is the Method for Inexperienced Practitioners? A Randomized Clinical Implementation in a Student Setting

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Sigmund Freud PrivatUniversitat · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alveolar Bone Loss
• Dental Implant
• Bone Augmentation

Interventions

Type	Name	Description
PROCEDURE	Socket Preservation	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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-03-01
• Completion: 2027-03-01
• First posted: 2024-08-06
• Last updated: 2024-08-06