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Completed

NCT Number: NCT03690167

Investigation of the Effects of CGF and A-PRF on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery

The objective of this case-control intervention study is to explore the effectiveness of Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF) on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery

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Key information

Conditions

Trismus Edema Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Op Complication Postoperative Complications Signs and Symptoms Spasm

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordu University

Ordu, 52200, Turkey (Türkiye)

About this study

In the present study, 75 patient, whose ages ranged between 18-30 and have an impacted lower third molar which is in vertical or mesiyoangular position and has class I and II ramus relationship and class B and C depth, will included. 75 patient will divided randomly into three groups as CGF, A-PRF and Control. After third molar surgery CGF and A-PRF will prepared and applied to the extraction sockets in CGF and A-PRF groups. nothing will applied to the control group. Post operative pain, edema and trismus will measured at 2nd and 7th days.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients presenting asymptomatic impacted lower third molar tooth in the vertical or mesioanguler position according to the Winter classification, Class I and II ramus relation and class B and C depth according to Pell-Gregory classification
  • Patients between the ages of 18-30,
  • Non-smokers,
  • Patients with ASA I status

Exclusion criteria

  • Who does not want to be volunteer for the study,
  • Do not comply with post-operative recommendations,
  • Operation lasting more than 30 minutes,
  • During pregnancy or lactation,
  • Have a chronic systemic disorder that may affect healing.
  • Unable to cooperate,
  • Post-operative infection,
  • Patients with pericoronitis

Treatment and study plan

Concentrated Growth Factor (CGF)

Other

CGF application (9 ml venous blood will harvested from the participants in the CGF group and centrifuged according to the protocol for CGF)

Advanced Platelet Rich Fibrin (A-PRF)

Other

A-PRF application (9 ml venous blood will harvested from the participants in the CGF group and centrifuged according to the protocol for A-PRF)

Control

Other

Nothing applied after extraction

Primary outcomes

  1. Edema-amount change of swelling

    Time frame: Baseline, 2nd and 7th days

    In order to evaluate the amount change of swelling after the operation, horizontal and vertical measurements will be made from 5 reference points including tragus, lip corner, soft tissue pogonion, lateral cantus of the eye and gonion. The first measurement between the tragus-lip corner, the second measurement will be obtained by measuring the horizontal distance between the tragus-soft tissue pogonion. The third measurement will be determined by the measurement of the vertical distance between the outer corner of the eye and the gonion. to determine the change in the swelling measurements performed before surgery and at 2nd-7th days after surgery.

Secondary outcomes

  1. Trismus- degree of change (limitation) in maximum mouth opening

    Time frame: Baseline, 2nd and 7th days

    The maximum mouth opening will be determined as the distance between the right lower and upper right central.

  2. Post operative Pain: visual analog (VAS) scale

    Time frame: 6th and 24th hours, 2nd and 7th days

    For the evaluation of the pain, the visual analog scale (VAS) will be used to express the absence of pain in the initial part on a straight line (0) and the end part to express the unbearable pain (10).

    0 (no pain)--------------------------------------------------------------------------------10 (unbearable pain) Higher values of the scale represent worse outcome.

  3. Post-operative symptom severity (PoSSe) scale

    Time frame: Post operative 7th day

    The evaluation of the change in postoperative quality of life will be done with a scale of post-operative symptom severity (PoSSe) consisting of 15-item questionnaire in which the effect of operation on eating, speech, sensation, appearance, pain, disease and daily activities is evaluated. This questionnaire was divided into subscales corresponding to seven main adverse effects, andfor each possible answer there was a score ranging from 0 to a variable number. For total possible answer there was a score ranging from 0 to a 97.9. Higher values of the scale represent worse outcome.

Sponsors and collaborators

Lead sponsor

Dr. Damla Torul

Other

Registry information

Official study title

Clinical Investigation of the Effects of Concentrated Growth Factor (CGF) and Advanced Platelet Rich Fibrin (A-PRF) on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2018
Registry last updated
Aug 28, 2019

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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