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

Study Overview
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Brief Summary
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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.

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

Conditions
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Wound Heal, Quality of Life, Dehiscence

Intervention / Treatment
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* Procedure: lower third molar extraction


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bayonet flap<br>Bayonet flap is performed to extract the the lower third molar | Procedure: lower third molar extraction<br>* the extraction is performed with one of the two type of flap based non randomization.<br>|
| Experimental: envelope flap<br>Envelope flap is performed to extract the the lower third molar | Procedure: lower third molar extraction<br>* the extraction is performed with one of the two type of flap based non randomization.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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third molar surgery, flaps, health related quality of life