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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06318247
Other study ID # 2022-134(R)
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date December 30, 2025

Study information

Verified date March 2024
Source The Dental Hospital of Zhejiang University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the clinical effect of site preservation after third molars extraction by using tooth extraction of third molars with site preservation using bio-oss and bio-guide in preventing the formation of deep periodontal pockets in the distal of second molars.


Description:

The mandibular third molar is the last tooth to erupt in the dentition, and due to the insufficient eruption position, it can lead to different degrees of impact. During the eruption of impacted tooth, the crown may be partially or completely covered by the gingival flap. A deep blind pocket is formed between the gingival flap and the tooth crown, and food and bacteria are easily impinged in the blind pocket. Under the influence of oral environment and dental plaque, the presence of blind pockets can lead to the loss of periodontal attachment and the absorption of alveolar bone, thus affecting the distal periodontal status of adjacent molars. Organic bone xenograft material composed of absorbable organic bovine hydroxyapatite is one of the commonly used transplantation materials for repairing bone defects. The application effect of allogeneic bone materials in periodontal therapy has been recognized by many experts and scholars. Guided bone regeneration (GBR), as a conventional periodontal bone graft, has achieved good results in periodontal tissue regeneration. Aljuboori et al. found that when the third molar was removed and GBR was performed at the same time, the depth of distal periodontal pocket probing of the adjacent second molar was significantly reduced in the re-examination 6 months after surgery. Hence, this study intends to use xenograft combined with barrier membrane to improve the formation of distal periodontal pocket of the second molars after third molars extraction.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 26 Years to 45 Years
Eligibility Inclusion Criteria: - 26-45 years old - Completely or partially impacted mandibular third molar - No evidence of acute inflammation - In good physical status and oral health - Regular attendance at control visits Exclusion Criteria: - pregnancy or lactation - Aggregate systemic pathologies such as diabetes, thyroid disorders, bone metabolism diseases, among others - Patients taking calcium, bisphosphonates, glucocorticoids, or other drugs that can interfere with bone metabolism - Patients with uncontrolled periodontal conditions, endodontic conditions and other oral disorders - Heavy smoke (10 cigarettes/day or more) - The second molar has no contact with the third molar, or the third molar crown has alveolar bone

Study Design


Intervention

Procedure:
site preservation
Tooth extraction of third molars with site preservation using bio-oss (0.5g, Small granule) and bio-guide (25*25mm size). The bone graft material used in the surgical procedure was provided by Geistlich Pharma AG.

Locations

Country Name City State
China Stomatology Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
The Dental Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Probing pocket depths (PPD) The depth of the periodontal pocket is examined with a periodontal probe. Probing pocket depths (PPD) measured in millimeters at six sites: disto-vestibular (DV), centro-vestibular (CV), mesio-vestibular (MV), disto-lingual (DL), centro-lingual(CL), mesio-lingual (ML) in postoperative 14days, 3, 6 and 12 months. The distal measurements are the primary outcomes. The higher the value, the worse the periodontal condition. postoperative 14 days, 3 6 and 12 months
Primary Distal bone wall defect (DBWD) The height of distal bone wall defect of the second mandibular molar is measured by cone-beam CT. postoperative 14 days, 3 6 and 12 months
Primary Clinical attachment lose (CAL) clinical attachment lose (CAL) were measured in millimeters at six sites: disto-vestibular (DV), centro-vestibular (CV), mesio-vestibular (MV), disto-lingual (DL), centro-lingual(CL), mesio-lingual (ML). The distal measurements are the primary outcomes. postoperative 14 days, 3 6 and 12 months
Primary Bleeding on probing (BOP) Periodontal probing for bleeding can determine whether the gingiva is in a state of inflammation or whether periodontal disease is in an active phase. postoperative 14 days, 3 6 and 12 months
Secondary Pain score Visual Analog Score for pain pre-operation, postoperative 14 days, 3 6 and 12 months
Secondary Patient satisfaction Physicians Global Assessment to measure quality of life pre-operation, postoperative 14 days, 3 6 and 12 months
Secondary Gingival index (GI) The higher the index, the worse the periodontal condition. pre-operation, postoperative 14 days, 3 6 and 12 months
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