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CompletedNCT06519409Updated Jul 29, 2024

Comparison of Bone Graft and Photodynamic Therapy in Class II Furcation

An interventional study of Open flap debridement and photodynamic therapy in Furcation Defects, sponsored by Krishnadevaraya College of Dental Sciences & Hospital. Completed at 1 site in India. Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-29.

Sponsored by Krishnadevaraya College of Dental Sciences & Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 3 months after the study started (first participant enrolled Apr 2016, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
25 Years to 60 Years
Sex
All
01

Study summary

This is a surgical comparative clinical trial which aims to assess class II buccal furcation defects treated with Xenograft alone or preceded by antimicrobial photodynamic therapy.

Read the detailed description

To test the efficacy of photodynamic therapy (Indocyanine green) along with placement of xenograft (Cerabone®-Natural bovine bone grafting material, Botiss biomaterials) to treat a class II furcation defects. The topical study was designed as a randomized controlled, single blinded (patient), split mouth clinical trial with 14 participants. In the control group, the defects were filled with xenograft (Cerabone®) whereas the test group received photodynamic therapy (Indocyanine green) in addition to grafting. Radiovisiography technique was used to observe the possible changes in the furcation region at baseline and 9 months postoperatively.

02

Conditions studied

  • Furcation Defects

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03

In context

Furcation Defects

42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.

This study's enrollment of 14 is below the median of 27 across 38 interventional studies indexed under Furcation Defects.

Browse Furcation Defects studies →

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital is the lead sponsor of 51 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Systemically healthy subjects Age group of 25-60 years Presence of class II furcation defect on buccal surfaces of mandibular molars as determined by clinical and radiographic evaluation.

Vertical probing depth (VPD) ≥4mm Horizontal probing depth (HPD) ≥4 mm Gingival margin (GM) coronal to or at the level of the roof of the furcation

Exclusion criteria

Exclusion Criteria:

Current and former smokers Administration of antibiotics in the last 6 months History of any periodontal therapy in the past 6 months Known allergic responses to bovine derived graft materials and photosensitizers.

Pregnant and lactating women.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Photodynamic therapy

    After debridement photodynamic therapy was performed by applying indocyanine green photo sensitizer to furcation defect sites for 1 min. A diode laser with the wavelength of 810 nm and 100 mW 0f power output in the continuous mode was applied to this site. The indocyanine dye has high absorption in the infrared spectrum with an absorption peak near 810 nm, which is close to the emission of diode lasers. This dye has low toxicity, a rapid elimination time and is a good photo sensitizer. The furcation defects then received the graft hydrated with sterile saline. The graft material compacted into the bone defect was similar to the control site.

    Procedure: Open flap debridement and photodynamic therapy

Interventions

  • ProcedureOpen flap debridement and photodynamic therapy
06

What researchers measure

Primary outcomes

  1. percentage of bone fill

    amount of bone formation

    Time frame: 9 months

Secondary outcomes

  1. Clinical efficacy

    clinical attachment level

    Time frame: 9 months

07

Study locations

1 site
  • Dr. Prabhuji MLV
    Bengaluru, Karnataka 562157, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2016 to primary completion in Jun 2016, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 26, 2023
First posted
Jul 25, 2024
StartActual
Apr 8, 2016
Primary completionActual
Jun 7, 2016
CompletionActual
May 11, 2017
Last update
Jul 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06519409
Lead sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Responsible party
Sponsor
First posted
Jul 25, 2024
Start date
Apr 8, 2016
Primary completion
Jun 7, 2016
Completion
May 11, 2017
Last update
Jul 29, 2024
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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