Skip to main content
OpenTrials
Completed

NCT Number: NCT04314765

Clinical Wound Healing After Lower 3rd Molar Fully-impacted Surgery With 2 Types of Flap

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Wound Heal Dehiscence Quality of Life

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pippi Roberto

Roma, Italy, 00161

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lower Third Molar Extraction

Procedure

the extraction is performed with one of the two type of flap based non randomization.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. quality of life day 2

    Time frame: 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.

  2. quality of life day 5

    Time frame: 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.

  3. quality of life day 7

    Time frame: 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.

  4. quality of life day 14

    Time frame: 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.

  5. dehiscence

    Time frame: 2 days after surgery

    a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing

  6. dehiscence

    Time frame: 7 days after surgery, at suture removal

    a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing

  7. dehiscence

    Time frame: 14 days after extraction

    a clinical chart is complete to evaluate if the presence of the dehiscence makes differences in surgical wound healing

  8. pre-operative symptoms

    Time frame: pre-operative

    the presence or not of pre operative Symptoms

  9. interincisive height

    Time frame: pre-operative

    the distance between upper and lower central incisors

  10. Full Mouth Plaque Score

    Time frame: 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

  11. Partial Plaque Score

    Time frame: 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

  12. type of impaction

    Time frame: pre-operative

    on orthopantomography

  13. Pell & Gregory class

    Time frame: intra-operative

    on orthopantomography

  14. depth of impaction

    Time frame: pre-operative

    on orthopantomography

  15. tooth position

    Time frame: pre-operative

    on orthopantomography

  16. description root morphology

    Time frame: pre-operative

    on orthopantomography; apical anomalies yes/no

  17. description number of roots

    Time frame: pre-operative

    on orthopantomography; 1/2/3/more than 3

  18. description of relationship with the second molar

    Time frame: pre-operative

    on orthopantomography; no contact/contiguity/overlap

  19. probing depth distal to the second molar

    Time frame: pre-operative

  20. quantity of keratinized gingiva

    Time frame: pre-operative

  21. position of the gingiva with respect to the CEJ (cemento-enamel junction) of the second molar

    Time frame: pre-operative

  22. maximum diameter of the bone cavity

    Time frame: intra-operative

  23. maximum depth of the bone cavity

    Time frame: intra-operative

    maximum depth of the bone cavity with respect to the CEJ of the second molar

  24. position of the gingiva

    Time frame: intra-operative

    position of the gingiva after the suture with respect to the CEJ (cemento-enamel junction) of the second molar

  25. duration of surgery

    Time frame: intra-operative

    extraction and suture

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Clinical Wound Healing After Fully-impacted Lower Third Molar Surgery Using Two Different Type of Flap: Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2020
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.