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RecruitingNCT06318247Updated Mar 19, 2024

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

An interventional study of site preservation in Periodontal Pocket, Periodontal Bone Loss and Impacted Third Molar Tooth, sponsored by The Dental Hospital of Zhejiang University School of Medicine. Recruiting at 1 site in China. Open to participants aged 26 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by The Dental Hospital of Zhejiang University School of Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
26 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Periodontal Pocket
  • Periodontal Bone Loss
  • Impacted Third Molar Tooth
03

In context

Alveolar Bone Loss

297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.

This study's planned enrollment of 30 is above the median of 25 across 254 interventional studies indexed under Alveolar Bone Loss.

Browse Alveolar Bone Loss studies →

Lead sponsor

The Dental Hospital of Zhejiang University School of Medicine is the lead sponsor of 25 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
26 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Sham comparator
    Control group

    Tooth extraction of third molars

    Procedure: site preservation

  • 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

Interventions

  • Proceduresite 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: postoperative 14 days, 3 6 and 12 months

  2. Distal bone wall defect (DBWD)

    The height of distal bone wall defect of the second mandibular molar is measured by cone-beam CT.

    Time frame: postoperative 14 days, 3 6 and 12 months

  3. 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.

    Time frame: postoperative 14 days, 3 6 and 12 months

  4. 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.

    Time frame: postoperative 14 days, 3 6 and 12 months

Secondary outcomes

  1. Pain score

    Visual Analog Score for pain

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

  2. Patient satisfaction

    Physicians Global Assessment to measure quality of life

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

  3. Gingival index (GI)

    The higher the index, the worse the periodontal condition.

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

07

Study locations

1 of 1 sites recruiting
  • Stomatology Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06318247
Lead sponsor
The Dental Hospital of Zhejiang University School of Medicine
Responsible party
Sponsor
First posted
Mar 19, 2024
Start date
Jun 1, 2023
Primary completion
Dec 30, 2024 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Mar 19, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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