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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Bone Loss; Impacted Third Molar Tooth; Periodontal Pocket
• Intervention / Treatment: Procedure: site preservation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Stomatology Hospital, Zhejiang University School of Medicine
      • Contact: Jue Shi, Doctor; Phone Number: +86 13757171359; Email: dentistsj@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group; Tooth extraction of third molars	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.
Experimental: GBR group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Visual Analog Score for pain	pre-operation, postoperative 14 days, 3 6 and 12 months
Patient satisfaction	Physicians Global Assessment to measure quality of life	pre-operation, postoperative 14 days, 3 6 and 12 months
Gingival index (GI)	The higher the index, the worse the periodontal condition.	pre-operation, postoperative 14 days, 3 6 and 12 months

Collaborators and Investigators

• Sponsor: The Dental Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: August 27, 2023
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Periodontitis; Alveolar Bone Loss; Periodontal Pocket
• Other Study ID Numbers: 2022-134(R)

Drug and device information, study documents

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