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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
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