NCT04314765

Brief Summary

The dehiscence distal to the second molar after lower third molar extraction is very common because the access flap for surgical extraction cannot be repositioned on a portion of healthy bone to guarantee suture support. The healing process is therefore delayed and the possible accumulation of food and debris is often responsible for bad smell and pain with the consequent occurrence of an overlapping infection. The main aim of the study is to evaluate whether healing is significantly different using two different flaps for surgical access. Clinical assessment and a quality of life questionnaire are used for the evaluation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 28, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

July 17, 2025

Status Verified

April 1, 2024

Enrollment Period

2.9 years

First QC Date

March 10, 2020

Last Update Submit

July 14, 2025

Conditions

Wound HealQuality of LifeDehiscence

Keywords

third molar surgeryflapshealth related quality of life

Outcome Measures

Primary Outcomes (3)

  • wound healing day 2

    a clinical chart is complete to evaluate if in the group of lower third molar extracted with a bayonet flap the proportion of healing without dehiscence (good healing index) is significant greater than in the group of third molar extracted with an envelope flap.

    2 days after surgery

  • wound healing day 7

    a clinical chart is complete to evaluate if in the group of lower third molar extracted with a bayonet flap the proportion of healing without dehiscence (good healing index) is significant greater than in the group of third molar extracted with an envelope flap.

    7 days after surgery, at suture removal

  • wound healing day 14

    a clinical chart is complete to evaluate if in the group of lower third molar extracted with a bayonet flap the proportion of healing without dehiscence (good healing index) is significant greater than in the group of third molar extracted with an envelope flap.

    14 days after surgery

Secondary Outcomes (25)

  • quality of life day 2

    2 days after surgery

  • quality of life day 5

    5 days after surgery

  • quality of life day 7

    7 days after surgery, at suture removal

  • quality of life day 14

    14 days after surgery

  • dehiscence

    2 days after surgery

  • +20 more secondary outcomes

Study Arms (2)

bayonet flap

EXPERIMENTAL

Bayonet flap is performed to extract the the lower third molar

Procedure: lower third molar extraction

envelope flap

EXPERIMENTAL

Envelope flap is performed to extract the the lower third molar

Procedure: lower third molar extraction

Interventions

lower third molar extractionPROCEDURE

the extraction is performed with one of the two type of flap based non randomization.

bayonet flapenvelope flap

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • fully-impacted lower third molar
  • patients aged between 18 and 35

You may not qualify if:

  • patients undergoing drug treatment for systemic diseases that can influenced the healing process,
  • pregnant women,
  • smoking habits
  • patients with disabilities
  • all interventions in which intraoperative accidents involving the soft tissues occurred (laceration of the mucosa / flap).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pippi Roberto

Roma, Italy, 00161, Italy

Location

Study Officials

  • Roberto Pippi, MDDS

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MDDS, associate Professor

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 19, 2020

Study Start

January 28, 2020

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

July 17, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)