Comparison Between Bioactive Silica Graft Plus Platelet Rich Fibrin and Only Platelet Rich Fibrin Graft in Intrabony Defects With Diabetes (CBBSGPPOPIDWD)
Evaluation of Efficacy of Bioactive Silica Graft With Platelet Rich Fibrin Vs Bioactive Silica Graft Alone In The Treatment Of Intrabony Defects In Patients With Type II Diabetes Mellitus -A Randomized Clinical Study.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Platelet rich fibrin has emerged as one of the promising regenerative material.It is a second generation platelet concentrate and is defined as an autologous leucocyte-and platelet-rich fibrin biomaterial.Platelet-rich fibrin membrane consists of a fibrin 3-D polymerized matrix in a specific structure ,with the incorporation of almost all the platelets and more than half of leucocytes along with growth factors.It enhance the stabilization and revascularization of the flaps and grafts.
Bioactive silica graft (Novabone dental putty )is being used for regenerative procedures is a premixed composite of bioactive calcium -phospho-silicate particulate which is composed solely of elements that exist naturally in normal bone (ca,p,na,si,o) and an absorbable binder which is a combination of polyethylene glycol and glycerine.Treatment of intrabony defects with bioactive silica graft has led to clinically and statistically significant probing depth reduction ,relative attachment level gain and radiographic osseous defect fill.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Telangana
-
Hyderabad, Telangana, Indien, 500060
- Panineya institute of dental sciences and research center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Two or three walled defects With relative clinical attachment loss ≥3mm Probing depth≥5mm Patients with known diabetes(Type 2 hbA1c 6 to 7.4)
Exclusion Criteria:
- One wall defects Other systemically compromised patients Non- compliant patients Individuals allergic to medication Pregnant or lactating mothers Smokers
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Interventional
Interventional The Group A subjects will be treated with conventional flap surgery.After reflection of the full thickness flap,the intrabony defects will be debrided and Bioactive silicate graft mixed with PRF will be used as graft material to fill the defects.
|
After administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back. After administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back. |
|
Aktiv komparator: Interventional comparator
Group B patients will also be treated by conventional flap surgery,employing a full thickness flap technique.The intrabony defects will be filled with Bioactive silicate only.
|
After administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back. After administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Radiographic parameters - Change in bone level
Tidsram: Baseline and 9 months post surgery.
|
Amount of bone fill in the intrabony defect (Change in bone level) to be measured by Cone Beam Computed Tomography (CBCT)
|
Baseline and 9 months post surgery.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
clinical parameters - Changes in relative clinical attachment level
Tidsram: Baseline and 9 months post surgery
|
Changes in relative clinical attachment level will be measured by UNC -15 probe in millimeters in the intrabony defect area
|
Baseline and 9 months post surgery
|
Samarbetspartners och utredare
Utredare
- Studierektor: Veerendra nath Reddy, MDS, panineeya institute of dental sciences and research center
Publikationer och användbara länkar
Allmänna publikationer
- Grover V, Kapoor A, Malhotra R, Uppal RS. Evaluation of the efficacy of a bioactive synthetic graft material in the treatment of intrabony periodontal defects. J Indian Soc Periodontol. 2013 Jan;17(1):104-10. doi: 10.4103/0972-124X.107484.
- Sharma A, Pradeep AR. Treatment of 3-wall intrabony defects in patients with chronic periodontitis with autologous platelet-rich fibrin: a randomized controlled clinical trial. J Periodontol. 2011 Dec;82(12):1705-12. doi: 10.1902/jop.2011.110075. Epub 2011 Apr 5.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- sravanthinovabone
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Intrabony periodontal defekt
-
Semmelweis UniversityRekryteringIntrabony periodontal defektUngern
-
Dr R Viswa ChandraRekryteringIntrabony periodontal defektIndien
-
Nova Southeastern UniversityRekryteringIntrabony periodontal defektFörenta staterna
-
Mansoura UniversityAvslutadIntrabony periodontal defektEgypten
-
October 6 UniversityAvslutad
-
Semmelweis UniversityGeistlich Pharma AG; Schupbach Ltd.AvslutadIntrabony periodontal defektUngern
-
Ain Shams UniversityAvslutadIntrabony periodontal defekt
-
Krishnadevaraya College of Dental Sciences & HospitalHar inte rekryterat ännu
-
Istituto Ortopedico GaleazziRekrytering
-
Cairo UniversityAvslutad
Kliniska prövningar på Conventional Flap Surgery
-
Inonu UniversityAvslutadStroke | Motoriska bilder | Action Observation Training | Graderade motorbilderTurkiet (Türkiye)
-
Recep Tayyip Erdogan UniversityAnmälan via inbjudanUtvärdering av effekterna av fyra olika flikdesigner på vävnadsläkning vid nedre tredje molarkirurgiMjukvävnadsskadorKalkon
-
King Abdullah University HospitalJordan University of Science and TechnologyRekryteringSårläkning | Palatal sår | Inflammatoriska cytokiner | Donator Site ComplicationJordanien
-
Vejle HospitalUniversity of Southern Denmark; Sygehus Lillebaelt; Region of Southern DenmarkAvslutad
-
Bulent Ecevit UniversityAvslutadParodontala sjukdomar | Parodontit, Aggressiv | Diodlaserterapi
-
University Hospital Inselspital, BerneAvslutad
-
Zagazig UniversityAvslutadPilonidal cysta och sinus utan abscessEgypten
-
The Cleveland ClinicIndragen
-
Anhui Provincial Cancer HospitalAnhui Provincial HospitalRekrytering
-
Diakonessenhuis, UtrechtRekryteringLivskvalité | Sömnapné, obstruktivNederländerna