Effect of CGF on Short Term Clinical Outcomes After Partially Impacted Mandibular Third Molar Surgery (CGF)
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|ClinicalTrials.gov Identifier: NCT03913884|
Recruitment Status : Completed
First Posted : April 12, 2019
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Trismus Edema||Procedure: Concentrated growth factor Other: Non-Concentrated growth factor Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|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|
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.
- 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'.
- 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.
- 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).
- presence of trismus [ Time Frame: Change of trismus at 7 days ]Inter-incisal distance was measured, as a guide point, with a millimeter ruler.
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
|Ege University, Faculty of Dentistry|
|İzmir, Bornova, Turkey, 35040|
|Principal Investigator:||Gözde Işık||Oral Surgery|