Clinical Wound Healing After Lower 3rd Molar Fully-impacted Surgery With 2 Types of Flap
- Conditions
- Quality of LifeWound HealDehiscence
- Interventions
- Procedure: lower third molar extraction
- Registration Number
- NCT04314765
- Lead Sponsor
- University of Roma La Sapienza
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 56
- fully-impacted lower third molar
- patients aged between 18 and 35
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description envelope flap lower third molar extraction Envelope flap is performed to extract the the lower third molar bayonet flap lower third molar extraction Bayonet flap is performed to extract the the lower third molar
- Primary Outcome Measures
Name Time Method wound healing day 14 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.
wound healing day 2 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.
wound healing day 7 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.
- Secondary Outcome Measures
Name Time Method quality of life day 2 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.
quality of life day 14 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.
Pell & Gregory class intra-operative on orthopantomography
tooth position pre-operative on orthopantomography
quality of life day 5 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.
quality of life day 7 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.
dehiscence 14 days after extraction a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing
pre-operative symptoms pre-operative the presence or not of pre operative Symptoms
interincisive height pre-operative the distance between upper and lower central incisors
type of impaction pre-operative on orthopantomography
Partial Plaque Score 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
Full Mouth Plaque Score 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
depth of impaction pre-operative on orthopantomography
description root morphology pre-operative on orthopantomography; apical anomalies yes/no
description of relationship with the second molar pre-operative on orthopantomography; no contact/contiguity/overlap
duration of surgery intra-operative extraction and suture
description number of roots pre-operative on orthopantomography; 1/2/3/more than 3
quantity of keratinized gingiva pre-operative maximum diameter of the bone cavity intra-operative probing depth distal to the second molar pre-operative position of the gingiva with respect to the CEJ (cemento-enamel junction) of the second molar pre-operative maximum depth of the bone cavity intra-operative maximum depth of the bone cavity with respect to the CEJ of the second molar
position of the gingiva intra-operative position of the gingiva after the suture with respect to the CEJ (cemento-enamel junction) of the second molar
Trial Locations
- Locations (1)
Pippi Roberto
🇮🇹Roma, Italy