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

NCT06318247 | Recruiting

• 1 other identifier: 2022-134(R)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontal Pocket; Periodontal Bone Loss; Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Pain score

  pre-operation, postoperative 14 days, 3 6 and 12 months

• Patient satisfaction

  pre-operation, postoperative 14 days, 3 6 and 12 months

• Gingival index (GI)

  pre-operation, postoperative 14 days, 3 6 and 12 months

Study Arms (2)

Control group

SHAM COMPARATOR

Tooth extraction of third molars

Procedure: site preservation

GBR group

EXPERIMENTAL

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

Interventions

site preservation PROCEDURE

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.

Control group; GBR group

Eligibility Criteria

• Age: 26 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Stomatology Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Periodontal Pocket; Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: March 19, 2024
• Study Start: June 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

CN (1)