Site Preservation After Tooth Extraction

Not yet recruiting

• Conditions: Osteogenesis Imperfecta; Total Absence of Permanent Teeth; Tooth Socket

• Registration Number: NCT05258019
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-30
• Study Start: 2023-11-01
• Primary Completion: 2026-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the alveolar crest width - central	up to 12 weeks after Dental extraction or site preservation surgery	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
Changes in the alveolar crest height - central	up to 12 weeks after Dental extraction or site preservation surgery	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

Secondary Outcome Measures

Name	Time	Method
Changes in the alveolar bone height - different horizontal sites	up to 12 weeks after Dental extraction or site preservation surgery	The height of the alveolar bone will be measured at the mesial, central and distal of buccal and lingual of alveolar crest,and the midpoint of the mesial and distal of interproximal sites with CBCT at 3 months after tooth extraction alone or plus site preservation
Plaque index (PLI)	up to 12 weeks after Dental extraction or site preservation surgery	Each tooth extraction socket will be measured on 6 sites: buccal, central and lingual of both mesial-distal sides
Bleeding index (BI)	up to 12 weeks after Dental extraction or site preservation surgery	Each tooth extraction socket will be measured on 6 sites: buccal, central and lingual of both mesial-distal sides
Phenotype assessment	up to 12 weeks after Dental extraction or site preservation surgery	Whether thick or thin gingival biotype will be detected by the transparency of the soft tissue while periodontal probing diagnosis
Soft tissue thickness	up to 12 weeks after Dental extraction or site preservation surgery	The thickness of soft tissue will be measured at middle, central, and distal sites of both buccal-lingual sides,3mm from free gingival margin
Changes in the alveolar bone width - different depths	up to 12 weeks after Dental extraction or site preservation surgery	The width of the alveolar bone at 1,3,5, and 7mm below the alveolar crest will be measured with CBCT at 3 months after tooth extraction or plus site preservation
Probing depth (PD)	up to 12 weeks after Dental extraction or site preservation surgery	Each tooth extraction socket will be measured on 6 sites: buccal, central and lingual of both mesial-distal sides
Pain degree	up to 12 weeks after Dental extraction or site preservation surgery.	The Visual Analogue Scale (VAS) pain score was evaluated: 0-10 (0: no pain; 1-3: slightly painful, acceptable; 4-6: painful, disrupt sleep, tolerable; 7-10: very painful, untolerable, affect sleep and diet)