Clinical trial NCT04314765: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Heal
Quality of Life
Dehiscence
Keywords: third molar surgery
flaps
health related quality of life
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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).

Primary outcomes:
measure: wound healing day 2
timeFrame: 2 days after surgery
measure: wound healing day 7
timeFrame: 7 days after surgery, at suture removal
measure: wound healing day 14
timeFrame: 14 days after surgery
Secondary outcomes:
measure: quality of life day 2
timeFrame: 2 days after surgery
measure: quality of life day 5
timeFrame: 5 days after surgery
measure: quality of life day 7
timeFrame: 7 days after surgery, at suture removal
measure: quality of life day 14
timeFrame: 14 days after surgery
measure: dehiscence
timeFrame: 2 days after surgery
measure: dehiscence
timeFrame: 7 days after surgery, at suture removal
measure: dehiscence
timeFrame: 14 days after extraction
measure: pre-operative symptoms
timeFrame: pre-operative
measure: interincisive height
timeFrame: pre-operative
measure: Full Mouth Plaque Score
timeFrame: pre-operative
measure: Partial Plaque Score
timeFrame: pre-operative
measure: type of impaction
timeFrame: pre-operative
measure: Pell & Gregory class
timeFrame: intra-operative
measure: depth of impaction
timeFrame: pre-operative
measure: tooth position
timeFrame: pre-operative
measure: description root morphology
timeFrame: pre-operative
measure: description number of roots
timeFrame: pre-operative
measure: description of relationship with the second molar
timeFrame: pre-operative
measure: probing depth distal to the second molar
timeFrame: pre-operative
measure: quantity of keratinized gingiva
timeFrame: pre-operative
measure: position of the gingiva with respect to the CEJ (cemento-enamel junction) of the second molar
timeFrame: pre-operative
measure: maximum diameter of the bone cavity
timeFrame: intra-operative
measure: maximum depth of the bone cavity
timeFrame: intra-operative
measure: position of the gingiva
timeFrame: intra-operative
measure: duration of surgery
timeFrame: intra-operative
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Pippi Roberto
Study officials:
affiliation: University of Roma La Sapienza
name: Roberto Pippi, MDDS
role: PRINCIPAL_INVESTIGATOR
References: