Furcation DefectsNCT01522131

Effect of Laser Use on Guided Tissue Regeneration in Treatment of Molar Teeth With Class 2 Furcation Affected by Periodontitis

A study of Furcation Defects and Periodontitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Purpose: The proposed study will evaluate and compare the clinical response of using bioresorbable collagen membrane alone or defect debridement with erbium Laser irradiation in conjunction with bioresorbable collagen membrane in the treatment of Class II furcation defects in maxillary and mandibular teeth. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Furcation Defects, Periodontitis, Alveolar Bone Loss Beyond Furcation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited States
Study dates: Dec 2011to Jun 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

should be 18 years of age in good general health
should exhibit an O'Leary plaque score of 20% or less after initial therapy
class II furcations defects should be present in the buccal of the maxillary molars or buccal or lingual of the mandibular molars
tooth mobility should not exceed Miller Class II

Who cannot join

patients who will be excluded include those with known hypersensitivity or allergy to chlorhexidine,
uncontrolled diabetics,
patients who are immunocompromised,
who have taken steroids within 6 months of study enrollment,
individuals who are pregnant and heavy smokers (> 10 cigarettes/day)

Trial locations and contacts

1 site in 1 country.

United States1 site

School of Dentistry ,Department of Periodontics,The University of Texas Health Science Center, Houston
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Treatment of Class II Furcation Defects in the Maxillary and Mandibular Molars With Bioresorbable Collagen Membrane and Laser

Procedure: The study will use 2 groups, a control group and a test group with 16 patients in each group, with severe chronic periodontitis having clinical or radiographic evidence of Class II furcation defects in the buccal or lingual of the mandibular molars or Class II furcation defects on the buccal of maxillary molars. 16 patients will serve as the control group and open flap debridement with bioresorbable collagen membrane will be the mode of treatment. Group 2: 16 patients will serve as the test group and will undergo open flap debridement in conjunction with Er, Cr: YSGG laser irradiation and a bioresorbable collagen membrane will be used.

Read the detailed description

All subjects will be patients of record in the Graduate Periodontics clinic at the UT School of Dentistry. These individuals will have already been diagnosed with chronic periodontitis and require surgical intervention to treat the disease process. All patients will have received initial periodontal therapy consisting of oral hygiene instructions and scaling and root planing. Once enrolled in the study, all subjects will receive surgical therapy involving opened flap debridement of the affected furcation defects along with membrane isolation of the defect. The test group will have debridement performed with the Er,Cr:YSGG laser and ultrasonic cleansing, while the control group will have hand instrumentation along with ultrasonic cleansing. This procedure will take approximately 1.5 hours. Postoperative appointments at 1,2,4,8 weeks requiring 15-30 minutes per appointment; at 3 months for periodontal maintenance and reinforcement of home care requiring 45 minutes; and at 6 months for periodontal maintenance, reassessment of the furcation defect and correction of residual defects requiring 75 minutes. Patients will be exited from the study 2 weeks after the last maintenance appointment and placed on recall with the Department of Periodontics dental hygienist. The total time commitment for each patient is 6 months.

Conditions: Furcation Defects, Periodontitis, Alveolar Bone Loss Beyond Furcation
Being tested: bioresorbable membrane alonewill be used for regeneration of the periodontium(control)
Keywords: bioresorbable membrane
Medical subject headings: Furcation Defects, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bioresorbable membrane alonewill be used for regeneration of the periodontium(control)Procedure or surgery
bioresorbable membrane with laser will be used for regeneration of the periodontium(test)

Study groups in NCT01522131
Study group	Role	What they receive
Bioresorbable membrane will be used as the control	Other	Bioresorbable membrane alone (control) Receives: Procedure: bioresorbable membrane alonewill be used for regeneration of the periodontium(control)
laser with bioresorabable membrane (test)	Experimental	Not described Receives: Procedure: bioresorbable membrane alonewill be used for regeneration of the periodontium(control)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Clinical Attachment( Gain or Loss) Measured by Horizontal Clinical Attachment Loss(in mm) From Baseline to 6 Months.
Patients with periodontitis lose bone and clinical attachment over a period of time. In both control and test a Nabers probe( curved probe) marked in mm was used to quantify this loss or gain of clinical attachment in a horizontal direction from the cemento-enamel junction to the the most apical extent of the bone at the furcation entrance at baseline and after 6months after the procedure. These measurements were done intrasurgery and before opening of the flaps,again both at initial visit and 6 months after the procedure was done. This measurement will be measured in mm in postive numbers and then will be compared to measurements ( in mm) at intial and baseline. If there is a loss in attachment it will be denoted by negative number. If theres a gain in attachment it will be denoted by a positive number after the comparison.
Measured: At Baseline and 6 months

Secondary outcomes (1)

Clinical Evidence of Regeneration of Class 2 Furcation Defects Based on Changes in Vertical Pocket Depth Measurement(in mm)
Patients with periodontitis lose bone and clinical attachment over a period of time in vertical direction also. In both control and test a UNC probe marked in mm was used to quantify this loss or gain of clinical attachment in a vertical direction from the cemento-enamel junction to the most apical extent of the bone at the furcation entrance at baseline and after 6months after the procedure. These measurements were done intrasurgery and before opening of the flaps,again both at initial visit and 6 months after the procedure was done.This measurement will be measured in mm in postive numbers and then will be compared to measurements ( in mm) at intial and baseline. Increase and decrease of vertical probing depth will be noted by a positive number.
Measured: At Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Jun 2013

First posted31 Jan 2012 (estimated)
Study startDec 2011
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Furcation DefectsStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01522131
Sponsor's protocol ID: HSC-DB-11-0611
Status last verified: Mar 2014
First submitted: 24 Jan 2012
Last updated: 12 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Gaspirc B, Skaleric U. Clinical evaluation of periodontal surgical treatment with an Er:YAG laser: 5-year results. J Periodontol. 2007 Oct;78(10):1864-71. doi: 10.1902/jop.2007.070054.
PubMed 18062108
Crespi R, Romanos GE, Cassinelli C, Gherlone E. Effects of Er:YAG laser and ultrasonic treatment on fibroblast attachment to root surfaces: an in vitro study. J Periodontol. 2006 Jul;77(7):1217-22. doi: 10.1902/jop.2006.050416.
PubMed 16805685
Pontoriero R, Lindhe J, Nyman S, Karring T, Rosenberg E, Sanavi F. Guided tissue regeneration in degree II furcation-involved mandibular molars. A clinical study. J Clin Periodontol. 1988 Apr;15(4):247-54. doi: 10.1111/j.1600-051x.1988.tb01578.x.
PubMed 3164333
Lekovic V, Kenney EB, Carranza FA Jr, Danilovic V. Treatment of class II furcation defects using porous hydroxylapatite in conjunction with a polytetrafluoroethylene membrane. J Periodontol. 1990 Sep;61(9):575-8. doi: 10.1902/jop.1990.61.9.575.
PubMed 2170618
Ishikawa I, Aoki A, Takasaki AA, Mizutani K, Sasaki KM, Izumi Y. Application of lasers in periodontics: true innovation or myth? Periodontol 2000. 2009;50:90-126. doi: 10.1111/j.1600-0757.2008.00283.x. No abstract available.
PubMed 19388956
Derdilopoulou FV, Nonhoff J, Neumann K, Kielbassa AM. Microbiological findings after periodontal therapy using curettes, Er:YAG laser, sonic, and ultrasonic scalers. J Clin Periodontol. 2007 Jul;34(7):588-98. doi: 10.1111/j.1600-051X.2007.01093.x.
PubMed 17555412
Melcher AH. On the repair potential of periodontal tissues. J Periodontol. 1976 May;47(5):256-60. doi: 10.1902/jop.1976.47.5.256. No abstract available.
PubMed 775048
Darley M. Students in Sweden. Nurs Stand (1984). 1984 Nov 22;(374):8. No abstract available.
PubMed 6568444

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Treatment of Class II Mandibular Furcation Defects
Class II Furcation Defect
Recruiting
Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Grade II Furcation Defects
Injectable Platelet-Rich Fibrin, Minimally Invasive
Recruiting
Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects
Class II Furcation Defect
Recruiting
Morphological Characteristics of Mandibular Molar Furcation Involvement and Efficacy of Regenerative Surgical Treatment
Periodontitis, Periodontitis (Stage 3)
Recruiting
Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements
Periodontitis, Furcation Defects

All Furcation Defects trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Class II Furcation Defects in the Maxillary and Mandibular Molars With Bioresorbable Collagen Membrane and Laser
ClinicalTrials.gov ID: NCT01522131
Acronym / sponsor ID: HSC-DB-11-0611
Conditions: Furcation Defects, Periodontitis, Alveolar Bone Loss Beyond Furcation
Keywords: bioresorbable membrane
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: Dec 2011
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 31 Jan 2012 (estimated)
Results: Posted 12 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bioresorbable membrane will be used as the control	Other	Procedure: bioresorbable membrane alonewill be used for regeneration of the periodontium(control)Bioresorbable membrane alone (control)
laser with bioresorabable membrane (test)	Experimental	Procedure: bioresorbable membrane alonewill be used for regeneration of the periodontium(control)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

should be 18 years of age in good general health
should exhibit an O'Leary plaque score of 20% or less after initial therapy
class II furcations defects should be present in the buccal of the maxillary molars or buccal or lingual of the mandibular molars
tooth mobility should not exceed Miller Class II

Key exclusion criteria (5 listed)

patients who will be excluded include those with known hypersensitivity or allergy to chlorhexidine,
uncontrolled diabetics,
patients who are immunocompromised,
who have taken steroids within 6 months of study enrollment,
individuals who are pregnant and heavy smokers (> 10 cigarettes/day)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bioresorbable membrane alonewill be used for regeneration of the periodontium(control)bioresorbable membrane with laser will be used for regeneration of the periodontium(test)	Procedure or surgery	Bioresorbable membrane will be used as the control, laser with bioresorabable membrane (test)

Primary outcome

Change in Clinical Attachment( Gain or Loss) Measured by Horizontal Clinical Attachment Loss(in mm) From Baseline to 6 Months.
Time frame: At Baseline and 6 months
Patients with periodontitis lose bone and clinical attachment over a period of time. In both control and test a Nabers probe( curved probe) marked in mm was used to quantify this loss or gain of clinical attachment in a horizontal direction from the cemento-enamel junction to the the most apical extent of the bone at the furcation entrance at baseline and after 6months after the procedure. These measurements were done intrasurgery and before opening of the flaps,again both at initial visit and 6 months after the procedure was done. This measurement will be measured in mm in postive numbers and then will be compared to measurements ( in mm) at intial and baseline. If there is a loss in attachment it will be denoted by negative number. If theres a gain in attachment it will be denoted by a positive number after the comparison.

1 secondary outcome

Clinical Evidence of Regeneration of Class 2 Furcation Defects Based on Changes in Vertical Pocket Depth Measurement(in mm)
Time frame: At Baseline and 6 months

Results and safety

Results posted to the registry on 12 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bioresorbable Membrane Will be Used as the Control	16	14
Laser With Bioresorabable Membrane (Test)	17	17

Primary outcome: Change in Clinical Attachment( Gain or Loss) Measured by Horizontal Clinical Attachment Loss(in mm) From Baseline to 6 Months.

Time frame: At Baseline and 6 months. Mean (Standard Deviation). Unit: mm

Measure	Bioresorbable Membrane Will be Used as the Control n = 14	Laser With Bioresorabable Membrane (Test) n = 17
Value	-.82 (1.54)	-1.26 (1.96)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bioresorbable Membrane Will be Used as the Control	0 of 14 (0%)	0 of 14 (0%)	Not reported
Laser With Bioresorabable Membrane (Test)	0 of 17 (0%)	0 of 17 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18062108Gaspirc B, Skaleric U. Clinical evaluation of periodontal surgical treatment with an Er:YAG laser: 5-year results. J Periodontol. 2007 Oct;78(10):1864-71. doi: 10.1902/jop.2007.070054.
Background: PubMed 16805685Crespi R, Romanos GE, Cassinelli C, Gherlone E. Effects of Er:YAG laser and ultrasonic treatment on fibroblast attachment to root surfaces: an in vitro study. J Periodontol. 2006 Jul;77(7):1217-22. doi: 10.1902/jop.2006.050416.
Background: PubMed 3164333Pontoriero R, Lindhe J, Nyman S, Karring T, Rosenberg E, Sanavi F. Guided tissue regeneration in degree II furcation-involved mandibular molars. A clinical study. J Clin Periodontol. 1988 Apr;15(4):247-54. doi: 10.1111/j.1600-051x.1988.tb01578.x.
Background: PubMed 2170618Lekovic V, Kenney EB, Carranza FA Jr, Danilovic V. Treatment of class II furcation defects using porous hydroxylapatite in conjunction with a polytetrafluoroethylene membrane. J Periodontol. 1990 Sep;61(9):575-8. doi: 10.1902/jop.1990.61.9.575.
Background: PubMed 19388956Ishikawa I, Aoki A, Takasaki AA, Mizutani K, Sasaki KM, Izumi Y. Application of lasers in periodontics: true innovation or myth? Periodontol 2000. 2009;50:90-126. doi: 10.1111/j.1600-0757.2008.00283.x. No abstract available.
Background: PubMed 17555412Derdilopoulou FV, Nonhoff J, Neumann K, Kielbassa AM. Microbiological findings after periodontal therapy using curettes, Er:YAG laser, sonic, and ultrasonic scalers. J Clin Periodontol. 2007 Jul;34(7):588-98. doi: 10.1111/j.1600-051X.2007.01093.x.
Background: PubMed 775048Melcher AH. On the repair potential of periodontal tissues. J Periodontol. 1976 May;47(5):256-60. doi: 10.1902/jop.1976.47.5.256. No abstract available.
Background: PubMed 6568444Darley M. Students in Sweden. Nurs Stand (1984). 1984 Nov 22;(374):8. No abstract available.

Related trials for Furcation Defects

RecruitingPhase 3
Treatment of Class II Mandibular Furcation Defects
Class II Furcation Defect
Recruiting
Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Grade II Furcation Defects
Injectable Platelet-Rich Fibrin, Minimally Invasive
Recruiting
Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects
Class II Furcation Defect
Recruiting
Morphological Characteristics of Mandibular Molar Furcation Involvement and Efficacy of Regenerative Surgical Treatment
Periodontitis, Periodontitis (Stage 3)
Recruiting
Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements
Periodontitis, Furcation Defects

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robin L Weltman, DDS,MSD study director

School of Dentistry ,Department of Periodontics,The University of Texas Health Science Center, Houston

Robin L Weltman, DDS,MSD study chair

School of Dentistry ,Department of Periodontics,The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Furcation Defects and Periodontitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Clinical Attachment( Gain or Loss) Measured by Horizontal Clinical Attachment Loss(in mm) From Baseline to 6 Months. (time frame: At Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01522131, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2014.