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

NCT01614925 | Terminated Results

• 1 other identifier: CR 02/11
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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 periodontal surgery without Straumann® Emdogain.

Conditions

Periodontal Attachment Loss; Periodontal Diseases

Outcome Measures

Primary Outcomes (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.

  12 Months

Secondary Outcomes (7)

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

  12 months after baseline

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

  12 months after baseline

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

  4 weeks after baseline

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

  4 weeks after baseline

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

  12 months after baseline

Study Arms (2)

Emdogain

EXPERIMENTAL

Periodontal surgery with the additional use of Straumann® Emdogain

Device: Emdogain

Periodontal Surgery

ACTIVE COMPARATOR

Periodontal surgery alone

Procedure: Periodontal surgery

Interventions

Emdogain DEVICE

Periodontal surgery with the additional use of Straumann® Emdogain

Emdogain

Periodontal surgery PROCEDURE

Periodontal surgery alone

Periodontal Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Periodontal Attachment Loss; Periodontal Diseases

Condition Hierarchy (Ancestors)

Periodontal Atrophy; Mouth Diseases; Stomatognathic Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. This sponsor decision was based on commercial reasons and not linked to any safety concerns or new scientific knowledge.

Results Point of Contact

• Title: Michel Mallaun
• Organization: Straumann

michel.mallaun@straumann.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 1, 2020
• Results First Posted: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)