Site Preservation After Tooth Extraction

Osteogenesis Imperfecta Clinical Trial

Official title:

Prospective Clinical Study on Site Preservation of Alveolar Ridge After Tooth Extraction Before Dental Implantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05258019
• Other study ID #: NFEC-2021-414
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: October 31, 2027

Study information

• Verified date: March 2023
• Source: Nanfang Hospital of Southern Medical University
• Contact: Qi Liu, Ph.D.
• Phone: +86 20 62787153
• Email: liuqi0721[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anodontia
• Osteogenesis Imperfecta
• Tooth Socket

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Changes in the alveolar bone width - different depths	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	up to 12 weeks after Dental extraction or site preservation surgery
Secondary	Changes in the alveolar bone height - different horizontal sites	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	up to 12 weeks after Dental extraction or site preservation surgery
Secondary	Soft tissue thickness	The thickness of soft tissue will be measured at middle, central, and distal sites of both buccal-lingual sides,3mm from free gingival margin	up to 12 weeks after Dental extraction or site preservation surgery
Secondary	Plaque index (PLI)	Each tooth extraction socket will be measured on 6 sites: buccal, central and lingual of both mesial-distal sides	up to 12 weeks after Dental extraction or site preservation surgery
Secondary	Bleeding index (BI)	Each tooth extraction socket will be measured on 6 sites: buccal, central and lingual of both mesial-distal sides	up to 12 weeks after Dental extraction or site preservation surgery
Secondary	Probing depth (PD)	Each tooth extraction socket will be measured on 6 sites: buccal, central and lingual of both mesial-distal sides	up to 12 weeks after Dental extraction or site preservation surgery
Secondary	Phenotype assessment	Whether thick or thin gingival biotype will be detected by the transparency of the soft tissue while periodontal probing diagnosis	up to 12 weeks after Dental extraction or site preservation surgery
Secondary	Pain degree	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)	up to 12 weeks after Dental extraction or site preservation surgery.