Site Preservation After Tooth Extraction

NCT05258019 | Not Yet Recruiting

• 1 other identifier: NFEC-2021-414
• Study Type: observational
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is mainly targeted affected teeth which could not be retained, and patients are willing to undergo implant repair at the later stage. After teeth extraction, Geistlich Bio-Oss ® Particles or Bio-Oss ® Collagen are immediately implanted in the teeth extraction socket and covered with Bio-Gide ® collagen membrane for site preservation.Through postoperative follow-up, postoperative clinical and imaging objective indicators, combined with the subjective evaluation of surgeons and patients, and compared with conventional extraction treatment method, the study is aimed to evaluate the effectiveness of different site preservation of alveolar crest preservation, in order to reduce the alveolar bone width and height loss, effectively reduce alveolar bone absorption, or even achieve bone incrementation, thus to get the ideal site preservation effect, to improve the oral implant success rate, improve implant aesthetic score and patient satisfaction, provide more clinical standard reference of the clinical application of site preservation.

Conditions

Osteogenesis Imperfecta; Total Absence of Permanent Teeth; Tooth Socket

Outcome Measures

Primary Outcomes (2)

• Changes in the alveolar crest height - central

  The central alveolar bone height of the ideal implant site will be measured with CBCT at 3 months after tooth extraction or plus site preservation

  up to 12 weeks after Dental extraction or site preservation surgery

• Changes in the alveolar crest width - central

  The central alveolar bone width of the ideal implant site will be measured with CBCT at 3 months after tooth extraction alone or plus site preservation

  up to 12 weeks after Dental extraction or site preservation surgery

Secondary Outcomes (8)

• Changes in the alveolar bone width - different depths

  up to 12 weeks after Dental extraction or site preservation surgery

• Changes in the alveolar bone height - different horizontal sites

  up to 12 weeks after Dental extraction or site preservation surgery

• Soft tissue thickness

  up to 12 weeks after Dental extraction or site preservation surgery

• Plaque index (PLI)

  up to 12 weeks after Dental extraction or site preservation surgery

• Bleeding index (BI)

  up to 12 weeks after Dental extraction or site preservation surgery

Study Arms (3)

Geistlich Bio-Oss ® Particles + Bio-Gide ® collagen membrane

The first group of patients selected for site preservation will be performed with Bio-Oss ® Particles + Bio-Gide ® collagen membrane after tooth extraction

Geistlich Bio-Oss ® Collagen + Bio-Gide ® collagen membrane

The second group of patients selected for site preservation will be performed with Bio-Oss ® Collagen + Bio-Gide ® collagen membrane after tooth extraction

Conventional healing after tooth extraction, without site preservation

The third group of patients selected will be performed without site preservation after tooth extraction, and only conventional healing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients who have teeth cannot be retained and are willing to do dental implant treatment at the teeth extration site.

You may qualify if:

• patients willing to performed site preservation with Geistlich Bio-Oss ® Particles + Bio-Gide ® collagen membrane after tooth extraction;
• patients willing to performed site preservation with Geistlich Bio-Oss ® Collagen + Bio-Gide ® collagen membrane after tooth extraction;
• patients willing to performed no site preservation after tooth extraction and only conventional healing.

You may not qualify if:

• patients unwilling to sign the informed consent form and the letter of authorization;
• patients has a potential systematic diseases;
• patients had previously been treated with radiation therapy;
• patients can not re-visit on time.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

MeSH Terms

Conditions

Osteogenesis Imperfecta

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Qi Liu, Ph.D.

CONTACT

+86 20 62787153; liuqi0721@smu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 28, 2022
• Study Start: November 1, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 30, 2023

Record last verified: 2023-03