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

Primary Purpose

Wound Heal, Quality of Life, Dehiscence

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
lower third molar extraction
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Wound Heal focused on measuring third molar surgery, flaps, health related quality of life

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Pippi RobertoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

bayonet flap

envelope flap

Arm Description

Bayonet flap is performed to extract the the lower third molar

Envelope flap is performed to extract the the lower third molar

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

quality of life day 2
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.
quality of life day 5
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.
quality of life day 7
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.
quality of life day 14
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.
dehiscence
a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing
dehiscence
a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing
dehiscence
a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing
pre-operative symptoms
the presence or not of pre operative Symptoms
interincisive height
the distance between upper and lower central incisors
Full Mouth Plaque Score
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
Partial Plaque Score
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
type of impaction
on orthopantomography
Pell & Gregory class
on orthopantomography
depth of impaction
on orthopantomography
tooth position
on orthopantomography
description root morphology
on orthopantomography; apical anomalies yes/no
description number of roots
on orthopantomography; 1/2/3/more than 3
description of relationship with the second molar
on orthopantomography; no contact/contiguity/overlap
probing depth distal to the second molar
quantity of keratinized gingiva
position of the gingiva with respect to the CEJ (cemento-enamel junction) of the second molar
maximum diameter of the bone cavity
maximum depth of the bone cavity
maximum depth of the bone cavity with respect to the CEJ of the second molar
position of the gingiva
position of the gingiva after the suture with respect to the CEJ (cemento-enamel junction) of the second molar
duration of surgery
extraction and suture

Full Information

First Posted
March 10, 2020
Last Updated
April 28, 2021
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT04314765
Brief Title
Clinical Wound Healing After Lower 3rd Molar Fully-impacted Surgery With 2 Types of Flap
Official Title
Clinical Wound Healing After Fully-impacted Lower Third Molar Surgery Using Two Different Type of Flap: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 28, 2020 (Actual)
Primary Completion Date
December 20, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal, Quality of Life, Dehiscence
Keywords
third molar surgery, flaps, health related quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bayonet flap
Arm Type
Experimental
Arm Description
Bayonet flap is performed to extract the the lower third molar
Arm Title
envelope flap
Arm Type
Experimental
Arm Description
Envelope flap is performed to extract the the lower third molar
Intervention Type
Procedure
Intervention Name(s)
lower third molar extraction
Intervention Description
the extraction is performed with one of the two type of flap based non randomization.
Primary Outcome Measure Information:
Title
wound healing day 2
Description
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.
Time Frame
2 days after surgery
Title
wound healing day 7
Description
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.
Time Frame
7 days after surgery, at suture removal
Title
wound healing day 14
Description
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.
Time Frame
14 days after surgery
Secondary Outcome Measure Information:
Title
quality of life day 2
Description
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.
Time Frame
2 days after surgery
Title
quality of life day 5
Description
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.
Time Frame
5 days after surgery
Title
quality of life day 7
Description
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.
Time Frame
7 days after surgery, at suture removal
Title
quality of life day 14
Description
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.
Time Frame
14 days after surgery
Title
dehiscence
Description
a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing
Time Frame
2 days after surgery
Title
dehiscence
Description
a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing
Time Frame
7 days after surgery, at suture removal
Title
dehiscence
Description
a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing
Time Frame
14 days after extraction
Title
pre-operative symptoms
Description
the presence or not of pre operative Symptoms
Time Frame
pre-operative
Title
interincisive height
Description
the distance between upper and lower central incisors
Time Frame
pre-operative
Title
Full Mouth Plaque Score
Description
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
Time Frame
pre-operative
Title
Partial Plaque Score
Description
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
Time Frame
pre-operative
Title
type of impaction
Description
on orthopantomography
Time Frame
pre-operative
Title
Pell & Gregory class
Description
on orthopantomography
Time Frame
intra-operative
Title
depth of impaction
Description
on orthopantomography
Time Frame
pre-operative
Title
tooth position
Description
on orthopantomography
Time Frame
pre-operative
Title
description root morphology
Description
on orthopantomography; apical anomalies yes/no
Time Frame
pre-operative
Title
description number of roots
Description
on orthopantomography; 1/2/3/more than 3
Time Frame
pre-operative
Title
description of relationship with the second molar
Description
on orthopantomography; no contact/contiguity/overlap
Time Frame
pre-operative
Title
probing depth distal to the second molar
Time Frame
pre-operative
Title
quantity of keratinized gingiva
Time Frame
pre-operative
Title
position of the gingiva with respect to the CEJ (cemento-enamel junction) of the second molar
Time Frame
pre-operative
Title
maximum diameter of the bone cavity
Time Frame
intra-operative
Title
maximum depth of the bone cavity
Description
maximum depth of the bone cavity with respect to the CEJ of the second molar
Time Frame
intra-operative
Title
position of the gingiva
Description
position of the gingiva after the suture with respect to the CEJ (cemento-enamel junction) of the second molar
Time Frame
intra-operative
Title
duration of surgery
Description
extraction and suture
Time Frame
intra-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Pippi, MDDS
Phone
+39 0649976650
Email
roberto.pippi@uniroma1.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Pippi, MDDS
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pippi Roberto
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Pippi, MDDS
Phone
+39 3356616181
Email
roberto.pippi@uniroma1.it

12. IPD Sharing Statement

Plan to Share IPD
No

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

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