An interventional study of lower third molar extraction in Wound Heal, Quality of Life and Dehiscence, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Supportive care
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.
University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bayonet flap is performed to extract the the lower third molar
Procedure: lower third molar extraction
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days after surgery
dehiscence
a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing
Time frame: 2 days after surgery
dehiscence
a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing
Time frame: 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
Time frame: 14 days after extraction
pre-operative symptoms
the presence or not of pre operative Symptoms
Time frame: pre-operative
interincisive height
the distance between upper and lower central incisors
Time frame: 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
Time frame: 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
Time frame: pre-operative
type of impaction
on orthopantomography
Time frame: pre-operative
Pell & Gregory class
on orthopantomography
Time frame: intra-operative
depth of impaction
on orthopantomography
Time frame: pre-operative
tooth position
on orthopantomography
Time frame: pre-operative
description root morphology
on orthopantomography; apical anomalies yes/no
Time frame: pre-operative
description number of roots
on orthopantomography; 1/2/3/more than 3
Time frame: pre-operative
description of relationship with the second molar
on orthopantomography; no contact/contiguity/overlap
Time frame: pre-operative
probing depth distal to the second molar
Time frame: pre-operative
quantity of keratinized gingiva
Time frame: pre-operative
position of the gingiva with respect to the CEJ (cemento-enamel junction) of the second molar
Time frame: pre-operative
maximum diameter of the bone cavity
Time frame: intra-operative
maximum depth of the bone cavity
maximum depth of the bone cavity with respect to the CEJ of the second molar
Time frame: 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
Time frame: intra-operative
duration of surgery
extraction and suture
Time frame: intra-operative
Plan to share: No
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University of Roma La Sapienza