NCT03804086

Brief Summary

this study is to evaluate the use of advanced platelet rich fibrin (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) versus open flap debridement alone in the management of mandibular molar grade II defects. In the management of mandibular molar grade II furcation defects, no difference exists in gain of horizontal clinical attachment level between the use of advanced platelet rich fibrin (A-PRF) + with nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) and open flap debridement (OPD) alone .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

9 months

First QC Date

January 11, 2019

Last Update Submit

January 15, 2019

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Relative Vertical Clinical Attachment Level (RVCAL)

    relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe

    6 months

Secondary Outcomes (3)

  • Relative Horizontal Clinical Attachment Level (PHCAL)

    6 months

  • Probing Depth (PD)

    6 months

  • Gingival margin Level (GML)

    6 months

Study Arms (2)

Test Group

EXPERIMENTAL

Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OFD).

Procedure: Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement

Control Group

ACTIVE COMPARATOR

Open flap debridement alone.

Procedure: Open flap debridement

Interventions

Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridementPROCEDURE

will treated with OFD +A- PRF+ nano-crystalline hydroxyapatite bone substitute,10 mL of blood will be drawn from only patient assigned to the intervention group by vein puncture of the antecubital vein and is collected in sterile glass test tube, without any anticoagulant. * The blood will be quickly collected, and the tube will immediately centrifuge at 1500 rpm for14 min at room temperature. * After centrifugation, the A-PRF clot will be removed from the tube using sterile tweezers and placed on sterile woven gauze. Membrane will prepared by compressing clots between two pieces of woven gauze.

Test Group
Open flap debridementPROCEDURE

a periodontal access flap will be initiated by intrasulcular incisions on the buccal and lingual aspects. The incisions will be carried as far interproximally as possible to preserve the entire Interdental papillae and to achieve primary wound closure.

Control Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient-related criteria:
  • Systemically healthy patients.
  • Compliance with oral hygiene instructions and the maintenance program provided.
  • Accepts the 6 months follow-up period.
  • Provide informed consent.
  • Teeth related criteria:
  • Mature permanent tooth.
  • Asymptomatic mandibular molar with buccal Glickman class II furcation involvement.
  • Probing depth (PD) ≥ 5 mm and vertical PD ≥ 3 mm after Phase I therapy (scaling and root planing).
  • Presence of radiolucency in the furcation area on an intra-oral periapical radiograph

You may not qualify if:

  • Patient-related criteria:
  • Patients taking drugs known to interfere with periodontal wound healing in the last six months.
  • Pregnant or nursing women.
  • Smokers.
  • Uncooperative patients.
  • Teeth related criteria:
  • Teeth with interproximal supra-bony or intrabony defects.
  • Teeth with gingival recession.
  • Teeth with grade II or III mobility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 15, 2019

Study Start

February 1, 2019

Primary Completion

November 1, 2019

Study Completion

February 1, 2020

Last Updated

January 17, 2019

Record last verified: 2019-01