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Periodontal Attachment LossNCT01614925

Safety and Efficacy of Periodontal Surgery in Supra-alveolar-type Defects With or Without Straumann® Emdogain

A study testing Emdogain and Periodontal surgery in people with Periodontal Attachment Loss and Periodontal Diseases, run by Institut Straumann AG at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this study is to demonstrate that in supra-alveolar-type defects (i.e., defects displaying a predominately horizontal pattern of bone loss), periodontal surgery with the additional use of Straumann® Emdogain will result in significantly higher Clinical Attachment Level (CAL) gain compared to… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Emdogain and Periodontal surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Nov 2012to Oct 2014
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have advanced periodontitis:
  • presence of supra-alveolar-type defects (i.e., defects displaying a predominantly horizontal pattern of bone loss) at a minimum of two adjacent teeth and a maximum of 7 adjacent teeth (FDI positions 17-27 or 37-47) in either the maxilla or the mandible with a PPD of ≥6 mm at a minimum on one site of the examined teeth
  • Teeth must have < Class II mobility
  • Teeth must have horizontal bone loss with an intrabony component of <2 mm as defined by radiographic evaluation
  • Subjects must have adequate oral hygiene (full mouth plaque index (PI) of <25% at baseline (i.e., following initial non-surgical periodontal therapy)
  • Subjects must have adequate control of inflammation (full mouth bleeding on probing (FMBP) of <25% at baseline (i.e., following initial non-surgical periodontal therapy)
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  • Subjects must have voluntarily signed the informed consent form before any study related procedures
  • Subjects must be males and females of at least 18 years of age
  • Subjects must be committed to the study and the required follow-up visits
  • Subjects must be in good general health as assessed by the investigator at time of surgery

Who cannot join

  • Pre-surgical exclusion criteria:
  • Subjects with any contraindications for oral surgical procedures
  • Subjects with uncontrolled diabetes or other uncontrolled systemic diseases
  • Subjects with disorders or treatments that compromise wound healing
  • Subjects with medical conditions requiring chronic high dose steroid therapy
  • Subjects with bone metabolic diseases
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  • Subjects with radiation or other immuno-oppressive therapy
  • Subjects with infections or vascular impairment at the surgical site
  • Subjects who are on antibiotic treatment or chronic anti-inflammatory treatment (≥3 times per week) within 4 weeks prior to surgery.
  • Subjects with the presence of oral lesions (such as ulceration, malignancy)
  • Subjects with mucosal diseases (e.g., lichen planus, mouth ulcer)
  • Subjects with a history of malignant disease in the oral cavity or previous radiotherapy to the head or neck
  • Subjects with inadequate oral hygiene or unmotivated for adequate home care
  • Subjects that have been treated with an investigational drug or device within the 30 day period immediately prior to surgery on study day 0.
  • Subjects who currently smoke
  • Female subjects who are nursing, pregnant, or plan to become pregnant
  • Secondary exclusion criteria:
  • Subjects with an osseous defect with an intrabony component of ≥2 mm or involving furcation involvement ≥ class II at the tooth of interest

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: A Randomized, Controlled, Multicenter Clinical Study Evaluating the Outcomes of Periodontal Surgery in Supra-alveolar-type Defects With or Without Straumann® Emdogain

The primary objective of this study is to demonstrate that in supra-alveolar-type defects (i.e., defects displaying a predominately horizontal pattern of bone loss), periodontal surgery with the additional use of Straumann® Emdogain will result in significantly higher Clinical Attachment Level (CAL) gain compared to periodontal surgery without Straumann® Emdogain.

Read the detailed description

The following secondary endpoints will be evaluated during the study:

  • Change in Gingival Margin (GM) at 12 months after surgery compared to baseline
  • Change in Probing Pocket Depth (PPD) at 12 months after surgery compared to baseline
  • Comparison of early wound healing index (EHI) at 4 weeks after surgery between treatment groups
  • Comparison of post-surgical pain at 4 weeks after surgery between treatment groups
  • Change in Bleeding on Probing (BoP) at 12 months after surgery compared to baseline
  • Change in root dentin hypersensitivity at 12 months after surgery compared to baseline
  • Change in full mouth plaque index (PI) at 12 months after surgery compared to baseline
Being tested
Emdogain, Periodontal surgery
Medical subject headings
Periodontal Attachment Loss, Periodontal Diseases

What participants receive

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

  • EmdogainDevice

    Periodontal surgery with the additional use of Straumann® Emdogain

  • Periodontal surgeryProcedure or surgery

    Periodontal surgery alone

Study groups in NCT01614925
Study groupRoleWhat they receive
EmdogainExperimentalPeriodontal surgery with the additional use of Straumann® Emdogain
Receives: Device: Emdogain
Periodontal SurgeryActive comparatorPeriodontal surgery alone
Receives: Procedure: Periodontal surgery

What is being measured

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

  1. Clinical Attachment Level

    The change in Clinical Attachment Level (CAL) from Baseline to 12 Months. CAL measurements will be derived from the Probing Pocket Depth (PPD) and Gingival Margin (GM) measurements as follows: CAL = PPD - GM.

    Measured: 12 Months

Secondary outcomes (7)

  1. Change in Gingival Margin (GM) From Baseline to 12 Months

    GM was measured by recording the distance from the Cemento-Enamel Junction (CEJ) to the margin of the gingiva at 6 sites (mesio-vestibular, mid-vestibular, disto-vestibular, mesio-oral, mid-oral, disto-oral) on the study teeth. Negative value for GM indicates gingival recession. A positive value for the GM indicates the gingiva was covering the CEJ.

    Measured: 12 months after baseline

  2. Change in Probing Pocket Depth (PPD) From Baseline to 12 Months

    PPD was measured before the area is anaesthetized by recording the distance from the gingival margin to the bottom of the probable pocket at 6 sites (mesio-vestibular, mid-vestibular, disto-vestibular, mesiooral, mid-oral, and disto-oral) on the study teeth.Negative value for PPD indicates reduction of pocket depth.

    Measured: 12 months after baseline

  3. Early Wound Healing Index (EHI) Assessment at 4 Weeks After Baseline

    Postoperative wound healing was assessed by the EHI according to Wachtel et al. [2003] by visual assessment:

    1. complete flap closure - no fibrin line in the interproximal area
    2. complete flap closure - fine fibrin line in the interproximal area
    3. complete flap closure - fibrin clot in the interproximal area
    4. incomplete flap closure - partial necrosis of the interproximal tissue
    5. incomplete flap closure - complete necrosis of the interproximal tissue The outcome measure was the percentage of EHI category 1 (complete flap closure - no fibrin line in the interproximal area)

    Measured: 4 weeks after baseline

  4. Comparison of Post-surgical Pain at 4 Weeks After Baseline

    Visual Analog Scale (VAS) for post-surgical pain, minimum value=0, maximum value=10, higher score means worse outcome

    Measured: 4 weeks after baseline

  5. Change in Bleeding on Probing (BoP) From Baseline to 12 Months

    The presence of BoP was recorded as a binary response on 6 sites (mesio-vestibular, midvestibular, disto-vestibular, mesio-oral, mid-oral, and disto-oral) on the study teeth. The percentage of positive events per total probing sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in BoP.

    Measured: 12 months after baseline

  6. Change in Root Dentin Hypersensitivity (RDH) From Baseline to 12 Months

    RDH was examined by physical testing using cold air as a stimulus. The percentage of positive events per total testing sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in RDH.

    Measured: 12 months after baseline

  7. Change in Plaque Index (PI) From Baseline to 12 Months

    The PI was recorded according to O'Leary et al. [1972] as a binary response at the mesial, distal, facial and lingual surfaces on the study teeth. The percentage of positive events per total sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in PI.

    Measured: 12 months after baseline

Timeline

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

  1. First posted8 Jun 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionOct 2014
  4. Study completionOct 2014

Why it stopped: Due to change in strategy and decision not to expand indication.

Resources

More details

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

Study design
Study type
Interventional
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01614925
Sponsor's protocol ID
CR 02/11
Status last verified
Nov 2020
First submitted
6 Jun 2012
Last updated
1 Dec 2020
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Emdogain and Periodontal surgery in people with Periodontal Attachment Loss and Periodontal Diseases, run by Institut Straumann AG 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 10 inclusion and 18 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: stopped early, as of the sponsor's last update on 1 Dec 2020. 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 1 Dec 2020). 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?

Clinical Attachment Level (time frame: 12 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 NCT01614925.

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 1 Dec 2020.

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