Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03703479
Other study ID # 085-10-17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 20, 2018
Est. completion date March 24, 2019

Study information

Verified date March 2019
Source King Abdulaziz University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the healing effect of advanced platelet-rich fibrin (blood clot charged with growth factors) taken from the patient own blood on the extraction site.


Description:

This is a randomized double-blind clinical study. A preoperative and radiographic evaluation will be done in order to select the patients.

Inclusion criteria are healthy patients above 18 years old with vertical or mesioangular bilateral impacted mandibular third molars. Exclusion criteria are missing second molars or indicated for extraction (un-restorable and remaining roots), patients under immunosuppressant and patients with acute infection. Those who fail to attend for follow-up appointments will be excluded.

The probing depth (PD) and clinical attachment level (CAL) distal to the second molar will be measured before each procedure. All patients will undergo bilateral removal of 3rd molar in a single appointment. Envelope flap with distal extension and a full-thickness mucoperiosteal flap will be utilized and the teeth will be removed with elevators. Bone removal will be utilized if needed.

Following the extraction, venous blood will be withdrawn to fill 2 tubes of 10mL each (sterile vacuum plain tube for A-PRF™ +). The blood tubes will be spun in the centrifugation machine for 13 minutes at 1300 rpm then it is pressed in PRF Box to form PRF clots which will be placed in one the extraction socket while the other socket will not receive a PRF (control).Randomization will be done using a coin toss.

Both extraction cavities will be closed using 3-4 interrupted sutures using 3.0 chromic gut sutures.

Postoperatively, all patients will be treated with oral antibiotic amoxicillin 500 mg and non-steroidal anti-inflammatory medications ibuprofen 600mg in case. also, all patients will be instructed to rinse with 0.2 % Chlorhexidine mouthwash for seven days postoperative.

On the 7th,15th and 90th days, patients will be asked about pain using visual analog scale (VAS) and whether they have any concern related to extraction socket statuses like halitosis, empty socket, open socket, dehiscence, and infection signs including swelling, pus, or fever.

They will also undergo a clinical examination at this visit and the consecutive visits. The following measures will be assessed during each clinical examination: the presence of a pocket distal to the adjacent second molar measuring the pocket depth and clinical attachment level and any signs of infection.

Data will be analyzed using statistical software. Analysis of multivariate regression will be used. The healing status will be compared between the graft site and the control site. Results will be interpreted to be statistically significant if they have a P-value of less than 0.05


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date March 24, 2019
Est. primary completion date February 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthy patients above 18 years old with mirror image vertical or mesioangular bilateral impacted mandibular third molars

Exclusion Criteria:

- Missing second molars or indicated for extraction (un-restorable and remaining roots).

- Patients under immunosuppressant and patients with acute infection.

- Patients who fail to attend for follow-up appointments.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
autologous blood clot made from the patient own clot without any additive
advanced Platelet-rich fibrin clot is made from venous blood withdrawn from the patient

Locations

Country Name City State
Saudi Arabia King Abdul Aziz University Jeddah Makkah

Sponsors (1)

Lead Sponsor Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss) Periodontal healing is evaluated based on changes in clinical attachment loss (mm) At baseline and at follow-up 4 weeks and 12 weeks after extraction
Secondary Pain reported by the patient according to the visual analogue scale (VAS) Pain reported by the patient according to the visual analogue scale (VAS) will be evaluated at first follow-up visit, the patient will score the pain suffered at each site on 0-10 scale where 0 = no pain and 10 = sever pain 7 days after the extraction
See also
  Status Clinical Trial Phase
Completed NCT05023135 - DeepView SnapShot Portable (DV-SSP): Device Training Study
Recruiting NCT03459547 - Soft Peri-implant Tissue Around Different Abutment Materials N/A
Recruiting NCT05608187 - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers Phase 2
Active, not recruiting NCT03649308 - Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting N/A
Recruiting NCT04596124 - Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze N/A
Completed NCT03285542 - Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty N/A
Recruiting NCT05689775 - Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Recruiting NCT05474911 - PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY. N/A
Recruiting NCT04849143 - The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation N/A
Completed NCT03596112 - The Difference in Wound Size Reduction Comparing Two Frequently Used Wound Dressings in Everyday Care N/A
Recruiting NCT05169814 - Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds Early Phase 1
Completed NCT04545476 - Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities N/A
Completed NCT06020157 - Comparison of Simple and Continuous Suture Techniques in Oral Surgery N/A
Recruiting NCT05133570 - Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities
Recruiting NCT04901325 - Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG) Phase 2
Withdrawn NCT03668665 - Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in "Split Wound Design" Phase 3
Recruiting NCT03204851 - Microlyte Dressing in the Management of Wounds N/A
Recruiting NCT06117436 - Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients Phase 2/Phase 3
Completed NCT05618912 - Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment N/A
Completed NCT05252260 - Comparison of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty N/A