Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02430519
Other study ID # 11/98/12
Secondary ID
Status Completed
Phase N/A
First received April 18, 2015
Last updated April 5, 2017
Start date September 2012
Est. completion date May 2013

Study information

Verified date April 2017
Source Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Furcation is the bifurcation or trifurcation of a multirooted tooth. It is an area of complex anatomic morphology difficult to debride by routine periodontal instrumentation. Multiple approaches have been used in an effort to treat the furcation Choukroun's platelet-rich fibrin (PRF), a second generation platelet concentrate has biochemical components which have well known synergetic effects on healing processes. The present study was conducted to evaluate the effectiveness of autologous platelet-rich fibrin (PRF) in the treatment of mandibular molar Grade 2 furcation defects in comparison to allograft and guided tissue regeneration (GTR) membrane.


Description:

ABSTRACT Background: Furcation is the bifurcation or trifurcation of a multirooted tooth. It is an area of complex anatomic morphology difficult to debride by routine periodontal instrumentation. Multiple approaches have been used in an effort to treat the furcation Choukroun's platelet-rich fibrin (PRF), a second generation platelet concentrate has biochemical components which have well known synergetic effects on healing processes. The present study was conducted to evaluate the effectiveness of autologous platelet-rich fibrin (PRF) in the treatment of mandibular molar Grade 2 furcation defects in comparison to allograft and guided tissue regeneration (GTR) membrane. MATERIALS AND METHODS: The study was designed as a randomized, prospective, parallel-arm, interventional clinical trial wherein 30 patients with periodontitis and grade II Mandibular furcation defects attending the Out Patient wing of the Department of Periodontics of a tertiary referral care hospital were equally divided into group A and group B. Patients in.Group A, were treated by the placement of PRF as a Graft and as a membrane at the surgical site , while in Group B, the defects were treated by the placement of Allograft and Healiguide collagen membrane. Plaque Index, Probing depth, Vertical clinical attachment level, Horizontal clinical attachment level, Gingival marginal level, and amount of bonefill using Radiovisiography were recorded at baseline and 9 months. Intra-group comparison of Mean scores between Group A and Group B was done using Paired t test and Inter-group comparison using independent sample t test. CONCLUSION Further studies evaluating the efficacy of PRF using a larger sample size should be performed to evaluate its true beneficial effects on long term basis in patients with mandibular molar Grade 2 furcation defects.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender All
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria:

- One or more sites showing grade II furcation involvement in mandibular molars, with Probing pocket depth = 5mm

- Vertical attachment level and horizontal level =3mm were considered.

- Patients who were systemically healthy, with no history of endodontic and periodontal treatment for the last 6 months, and no antibiotic usage for the last 6 months were included in the study. Care was taken to ascertain that the samples taken for the study were not allergic to any drugs nor to the graft materials used.

Exclusion Criteria:

- Patients with a history of diabetes, hypertension, on anticoagulant or steroid therapy (which could alter the effects of PRF), cardiac diseases, insufficient platelet counts and immunocompromised individuals were excluded from the study.

- Care was taken to exclude pregnant women and lactating mothers, smokers, patients with previous history of graft placement in the experimental site, and importantly those patients who were unable to maintain good oral hygiene (PI Score = 1.5).

- If Grade II mobility was observed after phase I therapy in the experimental teeth, they were excluded

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Furcation treatment with PRF
PRF Placed into the furcation after flap elevation and debridement
Furcation Treatment with Allograft and GTR
Allograft and GTR placed into furcation after flap elevation and debridement
Device:
allograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide)

autologous platelet-rich fibrin


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Dr.Syed Asimuddin

References & Publications (3)

Bosshardt DD, Sculean A. Does periodontal tissue regeneration really work? Periodontol 2000. 2009;51:208-19. doi: 10.1111/j.1600-0757.2009.00317.x. Review. — View Citation

Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radi — View Citation

Luepke PG, Mellonig JT, Brunsvold MA. A clinical evaluation of a bioresorbable barrier with and without decalcified freeze-dried bone allograft in the treatment of molar furcations. J Clin Periodontol. 1997 Jun;24(6):440-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Vertical clinical attacment level The Vertical clinical attachment level was assessed preoperatively and 9 months after surgery 9 months Post treatment
Primary Horizontal clinical attachment level The horizontal clinical attachment level was assessed preoperatively and 9 months after surgery. 9 months Post treatment
Primary Bone fill Bone fill was assessed radiographically and 9 months after surgery 9 months Post treatment
Secondary Plaque Index Plaque index was assessed preoperatively and 9 months after surgery 9 Months Post treatment
Secondary Probing depth Probing depth was assessed preoperatively and 9 months after surgery 9 Months Post treatment
Secondary Gingival marginal level Gingival marginal level was assessed preoperatively and 9 months after surgery 9 months post treatment
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06400069 - Role of NLRP6 in Chronic Periodontitis
Completed NCT05231096 - Comparison of the Effect of Gingival Massage of Aloe-vera Gel and Sidr Honey on Chronic Periodontitis N/A
Completed NCT03203746 - Gingival Crevicular Fluid Levels of Protein Carbonyl Following the Use of Lycopene in Chronic Periodontitis Phase 1/Phase 2
Active, not recruiting NCT03354338 - Amoxicillin to Prevent Bacteria and Inflammatory Biomarkers After Intensive Periodontal Therapy Phase 2
Completed NCT02516111 - Comparison of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Chronic Periodontitis Treatment Phase 2/Phase 3
Terminated NCT02568163 - Influence of Stress on Non Surgical Periodontal Treatment N/A
Completed NCT02174146 - Leptin and Visfatin in Diabetic Patients With Periodontitis Before and After Periodontal Therapy N/A
Completed NCT01233765 - Analysis of Neutrophil Response in Chronic Periodontitis N/A
Completed NCT01438333 - Efficacy of INERSAN in Patients With Chronic Periodontitis as Adjunctive to Full Mouth Disinfection N/A
Completed NCT02218515 - Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft Phase 4
Completed NCT02197260 - Antimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of Timing Phase 4
Not yet recruiting NCT03270280 - Comparison of Salivary Interleukin-1β and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis Phase 2
Not yet recruiting NCT04026828 - Evaluation of Possible Genes in Periodontal Diseases by Genetic Methods
Completed NCT04643288 - Nanocrystalline Hydroxyapatite Bone Substitute for Treating Periodontal Intrabony Defects N/A
Completed NCT04697199 - The Adjunctive Effect of Probiotics to Non Surgical Treatment of Chronic Periodontitis Phase 1
Completed NCT03039244 - Evaluation of Antimicrobial Photodynamic Therapy as an Adjunct to Periodontal Treatment in Smokers N/A
Completed NCT02851823 - Combined Use of Er:YAG and Nd:YAG Laser N/A
Completed NCT03874390 - Effects of Ozone Therapy on Clinical Parameters and Inflammatory Cytokines in Chronic Periodontitis Patients N/A
Completed NCT02518152 - Platelet Rich Fibrin+1% Alendronate in Treatment of Chronic Periodontitis Phase 2/Phase 3
Completed NCT02898675 - Advantages of Autologous Platelet-Rich Fibrin Membrane on Growth Factor Levels and Periodontal Healing N/A