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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04314765
• Other study ID #: 5478/25.7.19
• Status: Recruiting
• Phase: N/A
• Start date: January 28, 2020
• Est. completion date: December 20, 2022

Study information

• Verified date: April 2021
• Source: University of Roma La Sapienza
• Contact: Roberto Pippi, MDDS
• Phone: +39 0649976650
• Email: roberto.pippi[@]uniroma1.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dehiscence
• Quality of Life
• Wound Heal
• Wounds and Injuries

Intervention

Procedure:
• lower third molar extraction
the extraction is performed with one of the two type of flap based non randomization.

Locations

Country	Name	City	State
Italy	Pippi Roberto	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

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