Using Xenograft Combined With Barrier Membrane to Improve the Formation of Deep Periodontal Pockets

Impacted Third Molar Tooth Clinical Trial

Official title:

Using Xenograft Combined With Barrier Membrane to Improve the Formation of Deep Periodontal Pockets in the Distal of the Mandibular Second Molar After the Extraction of the Third Molar

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318247
• Other study ID #: 2022-134(R)
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Impacted Third Molar Tooth
• Periodontal Bone Loss
• Periodontal Pocket

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