Wound Heal, Quality of Life, Dehiscence
Conditions
Keywords
third molar surgery, flaps, health related quality of life
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.
Interventions
PROCEDURElower third molar extraction
the extraction is performed with one of the two type of flap based non randomization.
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| dehiscence | 2 days after surgery | 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 |
| 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 |
| 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 |
| type of impaction | pre-operative | on orthopantomography |
| Pell & Gregory class | intra-operative | on orthopantomography |
| depth of impaction | pre-operative | on orthopantomography |
| tooth position | pre-operative | on orthopantomography |
| 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. |
| description number of roots | pre-operative | on orthopantomography; 1/2/3/more than 3 |
| description of relationship with the second molar | pre-operative | on orthopantomography; no contact/contiguity/overlap |
| 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 | 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 |
| duration of surgery | intra-operative | extraction and suture |
| description root morphology | pre-operative | on orthopantomography; apical anomalies yes/no |
| 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. |
Countries
Italy
Outcome results
None listed