NCT06520137

Brief Summary

The aim of the study is to evaluate the changes in periodontal conditions on the distal aspect of the second maxillary molar after the extraction of the maxillary wisdom tooth. As secondary outcome patient- related and tooth-related factors will be analysed to evaluate their effects on the periodontal varibales during time.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Mar 2024Sep 2026

Study Start

First participant enrolled

March 27, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Expected
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

July 20, 2024

Last Update Submit

July 24, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Probing Pockeet Depth (PPD)

    Distance between the free gingival margin and the apical location of the probe's tip.

    Baseline, 1 month, 6 months, 12 months, 24 months

  • Bone Level (BL)

    Distance between the bone crest and the cemento-enamel junction (CEJ)

    Baseline, 1 month, 6 months, 12 months, 24 months

Secondary Outcomes (4)

  • Type of impaction

    Baseline

  • Clinical Attachment Level (CAL)

    Baseline, 1 month, 6 months, 12 months, 24 months

  • Recession (REC)

    Baseline, 1 month, 6 months, 12 months, 24 months

  • Keratinized Tissue (KT)

    Baseline, 1 month, 6 months, 12 months, 24 months

Study Arms (2)

Group A with PPD ≤ 3 mm

Procedure: Tooth extraction

Group B with PPD ≥ 4 mm

Procedure: Tooth extraction

Interventions

Extraction of maxillary third molars

Group A with PPD ≤ 3 mmGroup B with PPD ≥ 4 mm

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Hospital population.

You may qualify if:

  • Age more than 18 years or older
  • Presence of an impacted upper wisdom tooth that need to undergo surgical extraction
  • Participants need to be able to sign and understand the informed consent and to follow the study-related procedures.

You may not qualify if:

  • People that have compromised general health conditions (ASA 3, 4, 5, 6)
  • Patients that assumed antibiotics in the last 6 months
  • Pregnant or breastfeeding women
  • Patients who suffer from periodontitis stage III and IV
  • Presence of a third molar with incomplete root formation is not taken into account for the surgical extraction.
  • Smoker patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Siena

Siena, Italy/SI, 53100, Italy

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Tooth Extraction

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 20, 2024

First Posted

July 25, 2024

Study Start

March 27, 2024

Primary Completion

March 27, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

July 25, 2024

Record last verified: 2024-07

Locations