Clinical Wound Healing After Lower 3rd Molar Fully-impacted Surgery With 2 Types of Flap

July 14, 2025 updated by: Pippi Roberto, University of Roma La Sapienza

Clinical Wound Healing After Fully-impacted Lower Third Molar Surgery Using Two Different Type of Flap: Randomized Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Roma, Italy, 00161
        • Pippi Roberto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: bayonet flap
Bayonet flap is performed to extract the the lower third molar
Procedure: lower third molar extraction
the extraction is performed with one of the two type of flap based non randomization.
Experimental: envelope flap
Envelope flap is performed to extract the the lower third molar
Procedure: lower third molar extraction
the extraction is performed with one of the two type of flap based non randomization.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
wound healing day 2
Time Frame: 2 days after surgery
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
Time Frame: 7 days after surgery, at suture removal
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
Time Frame: 14 days after surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
quality of life day 2
Time Frame: 2 days after surgery
the patient complete a HRQOL questionnaire (modify from Shugars DA et al 1996) to evaluate if differences exist in the patient's quality of post-operative life in relation with two types of flap; we use visual analog scales (VAS) for post-operative pain and five-points Likert-Type for swelling, chewing, speaking, sleeping, sport and daily routine activity; higher scores mean a worse outcome.
2 days after surgery
quality of life day 5
Time Frame: 5 days after surgery
the patient complete a HRQOL questionnaire (modify from Shugars DA et al 1996) to evaluate if differences exist in the patient's quality of post-operative life in relation with two types of flap; we use visual analog scales (VAS) for post-operative pain and five-points Likert-Type for swelling, chewing, speaking, sleeping, sport and daily routine activity; higher scores mean a worse outcome.
5 days after surgery
quality of life day 7
Time Frame: 7 days after surgery, at suture removal
the patient complete a HRQOL questionnaire (modify from Shugars DA et al 1996) to evaluate if differences exist in the patient's quality of post-operative life in relation with two types of flap; we use visual analog scales (VAS) for post-operative pain and five-points Likert-Type for swelling, chewing, speaking, sleeping, sport and daily routine activity; higher scores mean a worse outcome.
7 days after surgery, at suture removal
quality of life day 14
Time Frame: 14 days after surgery
the patient complete a HRQOL questionnaire (modify from Shugars DA et al 1996) to evaluate if differences exist in the patient's quality of post-operative life in relation with two types of flap; we use visual analog scales (VAS) for post-operative pain and five-points Likert-Type for swelling, chewing, speaking, sleeping, sport and daily routine activity; higher scores mean a worse outcome.
14 days after surgery
dehiscence
Time Frame: 2 days after surgery
a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing
2 days after surgery
dehiscence
Time Frame: 7 days after surgery, at suture removal
a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing
7 days after surgery, at suture removal
dehiscence
Time Frame: 14 days after extraction
a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing
14 days after extraction
pre-operative symptoms
Time Frame: pre-operative
the presence or not of pre operative Symptoms
pre-operative
interincisive height
Time Frame: pre-operative
the distance between upper and lower central incisors
pre-operative
Full Mouth Plaque Score
Time Frame: pre-operative
Full-mouth plaque score was recorded dichotomously (presence/absence of plaque) on six sites per tooth and was then calculated as the percentage of total tooth surfaces that revealed the presence of plaque; higher percentage mean higher presence of plaque
pre-operative
Partial Plaque Score
Time Frame: pre-operative
Partial plaque score was recorded dichotomously (presence/absence of plaque) on six sites per tooth in the arch of extraction and was then calculated as the percentage of total tooth surfaces that revealed the presence of plaque; an higher percentage means higher presence of plaque
pre-operative
type of impaction
Time Frame: pre-operative
on orthopantomography
pre-operative
Pell & Gregory class
Time Frame: intra-operative
on orthopantomography
intra-operative
depth of impaction
Time Frame: pre-operative
on orthopantomography
pre-operative
tooth position
Time Frame: pre-operative
on orthopantomography
pre-operative
description root morphology
Time Frame: pre-operative
on orthopantomography; apical anomalies yes/no
pre-operative
description number of roots
Time Frame: pre-operative
on orthopantomography; 1/2/3/more than 3
pre-operative
description of relationship with the second molar
Time Frame: pre-operative
on orthopantomography; no contact/contiguity/overlap
pre-operative
probing depth distal to the second molar
Time Frame: pre-operative
pre-operative
quantity of keratinized gingiva
Time Frame: pre-operative
pre-operative
position of the gingiva with respect to the CEJ (cemento-enamel junction) of the second molar
Time Frame: pre-operative
pre-operative
maximum diameter of the bone cavity
Time Frame: intra-operative
intra-operative
maximum depth of the bone cavity
Time Frame: intra-operative
maximum depth of the bone cavity with respect to the CEJ of the second molar
intra-operative
position of the gingiva
Time Frame: intra-operative
position of the gingiva after the suture with respect to the CEJ (cemento-enamel junction) of the second molar
intra-operative
duration of surgery
Time Frame: intra-operative
extraction and suture
intra-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Roma La Sapienza

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roberto Pippi, MDDS, University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5478/25.7.19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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