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

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: Recruiting
• Conditions: Quality of Life; Wound Heal; Dehiscence
• Intervention / Treatment: Procedure: lower third molar extraction

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberto Pippi, MDDS; Phone Number: +39 0649976650; Email: roberto.pippi@uniroma1.it

Study Locations

• Italy
  • Roma, Italy, 00161
    • Recruiting
    • Pippi Roberto
    • Contact: Roberto Pippi, MDDS; Phone Number: +39 3356616181; Email: roberto.pippi@uniroma1.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Principal Investigator: Roberto Pippi, MDDS, University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Anticipated): December 20, 2022
• Study Completion (Anticipated): December 20, 2022

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: flaps; health related quality of life; third molar surgery
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID 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