Site Preservation After Tooth Extraction

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteogenesis Imperfecta; Tooth Socket; Total Absence of Permanent Teeth

• Study Type: Observational
• Enrollment (Anticipated): 88

Contacts and Locations

• Study Contact: Name: Qi Liu, Ph.D.; Phone Number: +86 20 62787153; Email: liuqi0721@smu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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.

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2023
• Primary Completion (Anticipated): October 31, 2026
• Study Completion (Anticipated): October 31, 2027

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Genetic Diseases, Inborn; Musculoskeletal Diseases; Connective Tissue Diseases; Stomatognathic Diseases; Bone Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Bone Diseases, Developmental; Tooth Abnormalities; Osteochondrodysplasias; Collagen Diseases; Osteogenesis Imperfecta; Anodontia
• Other Study ID Numbers: NFEC-2021-414

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No