Wound HealNCT04314765
Clinical Wound Healing After Lower 3rd Molar Fully-impacted Surgery With 2 Types of Flap
A study testing lower third molar extraction in people with Wound Heal and Quality of Life, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal, Quality of Life, Dehiscence
- What is being tested?
- lower third molar extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jan 2020to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- fully-impacted lower third molar
- patients aged between 18 and 35
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Wound Healing After Fully-impacted Lower Third Molar Surgery Using Two Different Type of Flap: Randomized Clinical Trial
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.
- Conditions
- Wound Heal, Quality of Life, Dehiscence
- Being tested
- lower third molar extraction
- Keywords
- third molar surgery, flaps, health related quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower third molar extractionProcedure or surgery
the extraction is performed with one of the two type of flap based non randomization.
| Study group | Role | What they receive |
|---|---|---|
| bayonet flap | Experimental | Bayonet flap is performed to extract the the lower third molar Receives: Procedure: lower third molar extraction |
| envelope flap | Experimental | Envelope flap is performed to extract the the lower third molar Receives: Procedure: lower third molar extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 14 days after surgery
Secondary outcomes (25)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 days after surgery
dehiscence
a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing
Measured: 2 days after surgery
dehiscence
a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing
Measured: 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
Measured: 14 days after extraction
pre-operative symptoms
the presence or not of pre operative Symptoms
Measured: pre-operative
interincisive height
the distance between upper and lower central incisors
Measured: 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
Measured: 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
Measured: pre-operative
type of impaction
on orthopantomography
Measured: pre-operative
Pell & Gregory class
on orthopantomography
Measured: intra-operative
depth of impaction
on orthopantomography
Measured: pre-operative
tooth position
on orthopantomography
Measured: pre-operative
description root morphology
on orthopantomography; apical anomalies yes/no
Measured: pre-operative
description number of roots
on orthopantomography; 1/2/3/more than 3
Measured: pre-operative
description of relationship with the second molar
on orthopantomography; no contact/contiguity/overlap
Measured: pre-operative
probing depth distal to the second molar
Measured: pre-operative
quantity of keratinized gingiva
Measured: pre-operative
position of the gingiva with respect to the CEJ (cemento-enamel junction) of the second molar
Measured: pre-operative
maximum diameter of the bone cavity
Measured: intra-operative
maximum depth of the bone cavity
maximum depth of the bone cavity with respect to the CEJ of the second molar
Measured: 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
Measured: intra-operative
duration of surgery
extraction and suture
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start28 Jan 2020
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pippi Roberto, University of Roma La Sapienza
- Investigators
- Roberto Pippi, MDDS, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314765
- Sponsor's protocol ID
- 5478/25.7.19
- Status last verified
- Apr 2024
- First submitted
- 10 Mar 2020
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Wound Healing After Fully-impacted Lower Third Molar Surgery Using Two Different Type of Flap: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04314765
- Acronym / sponsor ID
- 5478/25.7.19
- Conditions
- Wound Heal, Quality of Life, Dehiscence
- Keywords
- third molar surgery, flaps, health related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bayonet flap | Experimental | Procedure: lower third molar extractionBayonet flap is performed to extract the the lower third molar |
| envelope flap | Experimental | Procedure: lower third molar extractionEnvelope flap is performed to extract the the lower third molar |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- fully-impacted lower third molar
- patients aged between 18 and 35
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lower third molar extractionthe extraction is performed with one of the two type of flap based non randomization. | Procedure or surgery | bayonet flap, envelope flap |
Primary outcome
wound healing day 2
Time frame: 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
Time frame: 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
Time frame: 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.
25 secondary outcomes
quality of life day 2
Time frame: 2 days after surgery
quality of life day 5
Time frame: 5 days after surgery
quality of life day 7
Time frame: 7 days after surgery, at suture removal
quality of life day 14
Time frame: 14 days after surgery
dehiscence
Time frame: 2 days after surgery
dehiscence
Time frame: 7 days after surgery, at suture removal
dehiscence
Time frame: 14 days after extraction
pre-operative symptoms
Time frame: pre-operative
interincisive height
Time frame: pre-operative
Full Mouth Plaque Score
Time frame: pre-operative
Partial Plaque Score
Time frame: pre-operative
type of impaction
Time frame: pre-operative
Pell & Gregory class
Time frame: intra-operative
depth of impaction
Time frame: pre-operative
tooth position
Time frame: pre-operative
description root morphology
Time frame: pre-operative
description number of roots
Time frame: pre-operative
description of relationship with the second molar
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
Time frame: intra-operative
position of the gingiva
Time frame: intra-operative
duration of surgery
Time frame: intra-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Pippi, MDDS principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lower third molar extraction in people with Wound Heal and Quality of Life, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing day 2 (time frame: 2 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.