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Effect of CGF on Short Term Clinical Outcomes After Partially Impacted Mandibular Third Molar Surgery (CGF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03913884
Recruitment Status : Completed
First Posted : April 12, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Gözde Işık, Ege University

Brief Summary:
The aim of this study was to evaluate the effectiveness of concentrated growth factor (CGF) on soft tissue healing and postoperative side effects following third molar surgery. This study was designed on 60 patients as a randomized single-blind clinical trial. The predictor variable was the implementation of CGF fibrin matrix, which was categorized as CGF and non-CGF. The primary outcome variable of the study was the healing of soft tissue around the extraction socket. The secondary outcome variables were pain, swelling and trismus. Data were analyzed using the non-parametric Brunner and Langer model. Statistical significance was set at P < .001.

Condition or disease Intervention/treatment Phase
Postoperative Pain Trismus Edema Procedure: Concentrated growth factor Other: Non-Concentrated growth factor Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Concentrated Growth Factor (CGF) on Short Term Clinical Outcomes After Partially Impacted Mandibular Third Molar Surgery: A Split-Mouth Randomized Clinical Study
Actual Study Start Date : April 4, 2018
Actual Primary Completion Date : August 19, 2018
Actual Study Completion Date : August 26, 2018

Arm Intervention/treatment
Experimental: Concentrated growth factor Group
Group I (test); in which CGF fibrin matrix was applied to the extraction socket
Procedure: Concentrated growth factor
CGF fibrin matrix was placed in one socket which was randomly selected (test side). The flap was sutured with 4/0 atraumatic silk suture (½ cutting edge, 75 cm, Doğsan, İstanbul, Turkey) for each surgical site.

Experimental: Non-Concentrated growth factor Group
Group II (control); in which CGF was not applied to the extraction socket
Other: Non-Concentrated growth factor Group
To control group, extraction of the tooth on the opposite site was performed and the socket left to heal naturally. The flap was sutured with 4/0 atraumatic silk suture (½ cutting edge, 75 cm, Doğsan, İstanbul, Turkey) for each surgical site.




Primary Outcome Measures :
  1. soft tissue healing [ Time Frame: Change of soft tissue healing at 7 days ]
    This was assessed on the third and seventh preoperative days using the healing index classified by Landry et al.12. It depends on tissue colour, presence of bleeding on palpation, epithelization of wound margins, granulation tissue and suppuration, and rates the degree of healing attained from 'very poor' to 'excellent'.


Secondary Outcome Measures :
  1. severity of postoperative pain [ Time Frame: Change of postoperative pain at 7 days ]
    The patients were instructed to note their level of postoperative discomfort and/or pain on the scale, which ranged from 0, indicating no pain, to 100 indicating the worst ever experienced. Paracetamol (500-mg tablets) was prescribed to be taken postoperatively as needed. The patients were asked to fill in the questionnaire as required on a daily basis for 7 days.

  2. presence of swelling [ Time Frame: Change of swelling at 7 days ]
    three facial measurements were taken with milimetric elastic ruler, preoperatively, as described by Kumar et al., on the third and seventh days after extraction. These dimensions were as follows: the from the tragus to the pogonion (TP); from the tragus to the corner of the mouth (TC); and from the lateral corner of the eye to the angle of the mandible (EA).

  3. presence of trismus [ Time Frame: Change of trismus at 7 days ]
    Inter-incisal distance was measured, as a guide point, with a millimeter ruler.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1- Bilateral, vertically, partially-impacted Class I, Level B third molars

Exclusion Criteria:

  1. Infection of the surgical region
  2. Smoking habit
  3. Alcohol usage
  4. Physical or mental disability
  5. Thrombocytopenia
  6. Chemotherapy in head and neck region
  7. Pregnant woman or woman in menstrual cycle

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913884


Locations
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Turkey
Ege University, Faculty of Dentistry
İzmir, Bornova, Turkey, 35040
Sponsors and Collaborators
Ege University
Investigators
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Principal Investigator: Gözde Işık Oral Surgery

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gözde Işık, Oral Surgery, Ege University
ClinicalTrials.gov Identifier: NCT03913884    
Other Study ID Numbers: Faculty of Dentistry
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gözde Işık, Ege University:
Impacted third molar surgery
Clinical outcomes
Concentrated growth factor
Additional relevant MeSH terms:
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Tooth, Impacted
Trismus
Neurologic Manifestations
Signs and Symptoms
Tooth Diseases
Stomatognathic Diseases
Spasm
Neuromuscular Manifestations
Nervous System Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action