Mansoura university Faculty of dentistry
Al Mansurah, Mansoura, 35516, Egypt
Location status: Recruiting
Location contact
HUSAIN A.JALIL ALAM, BDS
PRINCIPAL_INVESTIGATOR
husain a.jalil alam, BDS
CONTACT
NCT Number: NCT07081230
The primary objective is to clinically evaluate the efficacy of albumin versus hyaluronic acid scaffolds in combination with concentrated growth factors in the non- surgical treatment of stage II/III periodontitis.
The secondary objective is to evaluate the duration and concentration of different growth factors release in the gingival crevicular fluid.
Interested in participating?
Request Info25 year–45 year
All sexes
Interventional
Not applicable
Al Mansurah, Mansoura, 35516, Egypt
Location status: Recruiting
HUSAIN A.JALIL ALAM, BDS
PRINCIPAL_INVESTIGATOR
husain a.jalil alam, BDS
CONTACT
III. Treatment Procedures:
Three weeks prior to treatment all patients will receive phase I periodontal therapy in the form of non-surgical mechanical debridement using ultrasonic and hand instruments, oral hygiene instructions will be demonstrated to all patients.
Group I (Test group 1): will receive mechanical debridement and injection of hyaluronic acid mixed with growth factor concentrates in the periodontal pocket, the growth factor concentrates will be prepared by collecting peripheral blood using 9-10 mL tubes without adding any additives, following blood collection, the blood tubes will be placed in a centrifuge for the 8-min ,two to four milliliters of the initial portion of plasma PPP (platelet-poor plasma) is then collected with a syringe and discarded, leaving the other blood portions, the LPCGF (liquid phase concentrated growth factors) from buffy coat is collected then it will be mixed using a female-female connector with hyaluronic acid and injected into the pocket.
Group II (Test group 2) : will receive mechanical debridement and ALB-PRF will be prepared by collecting peripheral blood using 9-10 mL tubes without adding any additives, following blood collection, the blood tubes will be placed in a centrifuge for the 8-min ,Two to four milliliters of the initial portion of plasma (platelet-poor plasma) is then collected with a syringe and placed into a heating device , while the other blood portions (buffy coat, LPCGF, and red blood cells) are placed in a cooling storage bag. The syringes containing PPP are then inserted into a heating device for human serum albumin denaturation plasma to produce the albumin gel. After 10 minutes at an operating temperature of 75°C, the syringes are then removed and allowed to cool in a cooling storage bag and protected from ambient light. The LPCGF (liquid phase concentrated growth factors) from buffy coat are then collected. Thereafter, the albumin gel and the liquid-CGF are mixed between syringes by passing back and forth (roughly 10×) using a female-female connector to create ALB-PRF which is ready to be injected in the periodontal pocket, ALB-PRF gel will be injected into periodontal pocket by special needle until it is full.
Group III (Control group): will receive mechanical debridement only. All patients will be advised not to eat hard food, they were also advised not to brush the area for 12h or to floss or use interproximal cleaning devices for ten days. During the study period, the patients were instructed to continue regular tooth brushing and interdental cleansing, also instructed not to use any mouth washes for the Duration of the study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
ii) Inclusion Criteria:
patients will receive hyaluronic acid mixed with concentrated growth factors injected into the periodontal pocket after mechanical debridement
patients will receive Albumin gel mixed with concentrated growth factors injected into the periodontal pocket after mechanical debridement
Time frame: baseline, 6weeks, 12weeks
0: No plaque is visible.
Time frame: baseline, 6weeks, 12weeks
"0" if no bleeding occurred within 10 second, and "1" if there was bleeding within 10 second.
Time frame: baseline, 6weeks, 12weeks
will be measured from the gingival margin to the base of the periodontal pocket
Time frame: baseline, 6weeks, 12weeks
will be measured from the cement-enamel junction to the base of the periodontal pocket
Contact information is provided by the study sponsor or research team.
husain abduljalil alam
Other
Comparison Between the Efficacy of Albumin Versus Hyaluronic Acid Scaffold in Combination With Concentrated Growth Factors as an Adjunct to Non-surgical Treatment of Periodontitis (Randomized Controlled Clinical Trial)
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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