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NCT Number: NCT06262841

Post-Surgical Morbidity and Bone Healing of Impacted Lower Third Molars: Piezosurgery vs. Conventional Instruments

The aim of this study is to compare piezosurgery and conventional surgery in impacted third molar surgery and to determine its effect on postoperative outcomes and quality of life.

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Key information

Conditions

Impacted Third Molar Tooth

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University Faculty of Dentistry

Ankara, Çankaya, 06510, Turkey (Türkiye)

About this study

The aim of our study is to comparatively evaluate the duration of the operation and the pain, trismus, edema and healing of the alveolar bone that occur after tooth extraction in surgical extractions of impacted lower third molar teeth using piezosurgery and traditional rotary instruments.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA I-II
  • Aged 18-35
  • Symmetrical Class 2 Position B according to Winter and Pell-gregory classification
  • Asymptomatic lower third molar tooth with the same difficulty according to the Yuasa difficulty index

Exclusion criteria

  • Individuals who had systemic disease affecting bone or soft tissue metabolism
  • Smokers (more than 10 cigarettes a day)
  • Alcohol dependent
  • Systemic disease affecting bone or soft tissue metabolism
  • Acute pericoronitis or acute periodontal disease at the time of operation, and used antibiotics due to acute infection

Treatment and study plan

Piezosurgery

Device

Piezosurgery used as an osteotomy device

Conventional burs

Device

Conventional burs used as an osteotomy device

Primary outcomes

  1. Change in Oral Health-related Quality of Life

    Time frame: Time Frame: 14 days

    Evaluated by Oral Health Impact Profile-14 questionnaire (OHIP-14). The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. The domain scores can range from 0 to 8. Higher OHIP-14 scores indicate worse and lower scores indicate better Oral Health Related Quality of Life.

Secondary outcomes

  1. Change in pain

    Time frame: 7 days

    Postoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable

  2. Change in Mouth opening

    Time frame: 7 days

    The distance between the mesio-incisal corners of the upper and lower central incisors was measured with the help of a ruler when the mouth opening was at its maximum.

  3. Operation time

    Time frame: Intraoperative

    The total time from the first incision of the operation site to the last suture was measured with the help of a digital stopwatch as the operation time.

  4. Change in facial swelling

    Time frame: 7 days

    With the technique described by Neupert ; Angle of mandible-tragus Angle of mandible-lateral canthus of eye Mandible corner-nose wing Angle of mandible oral-commissures Measurements were made with a tape measure from 5 points, with the mandible corner-pogonion.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Comparative Evaluation of Morbidity and Alveolar Bone Healing After Surgical Extraction of Impacted Lower Third Molar Teeth Using Piezosurgery and Conventional Instruments: A Split-Mouth Clinical Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2024
Registry last updated
Feb 16, 2024

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.

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