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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06318247
Enrollment
30
Registered
2024-03-19
Start date
2023-06-01
Completion date
2025-12-30
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impacted Third Molar Tooth, Periodontal Bone Loss, Periodontal Pocket

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.

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.

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.

Sponsors

The Dental Hospital of Zhejiang University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
26 Years to 45 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Probing pocket depths (PPD)postoperative 14 days, 3 6 and 12 monthsThe 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.
Distal bone wall defect (DBWD)postoperative 14 days, 3 6 and 12 monthsThe height of distal bone wall defect of the second mandibular molar is measured by cone-beam CT.
Clinical attachment lose (CAL)postoperative 14 days, 3 6 and 12 monthsclinical 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.
Bleeding on probing (BOP)postoperative 14 days, 3 6 and 12 monthsPeriodontal probing for bleeding can determine whether the gingiva is in a state of inflammation or whether periodontal disease is in an active phase.

Secondary

MeasureTime frameDescription
Patient satisfactionpre-operation, postoperative 14 days, 3 6 and 12 monthsPhysicians Global Assessment to measure quality of life
Gingival index (GI)pre-operation, postoperative 14 days, 3 6 and 12 monthsThe higher the index, the worse the periodontal condition.
Pain scorepre-operation, postoperative 14 days, 3 6 and 12 monthsVisual Analog Score for pain

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026