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

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

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01614925

Enrollment

Registered

2012-06-08

Start date

2012-11-30

Completion date

2014-10-31

Last updated

2020-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Attachment Loss, Periodontal Diseases

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.

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

Interventions

DEVICEEmdogain

Periodontal surgery with the additional use of Straumann® Emdogain

PROCEDUREPeriodontal surgery

Periodontal surgery alone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

Pre-surgical

Design outcomes

Primary

Measure	Time frame	Description
Clinical Attachment Level	12 Months	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.

Secondary

Measure	Time frame	Description
Change in Probing Pocket Depth (PPD) From Baseline to 12 Months	12 months after baseline	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.
Early Wound Healing Index (EHI) Assessment at 4 Weeks After Baseline	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)
Comparison of Post-surgical Pain at 4 Weeks After Baseline	4 weeks after baseline	Visual Analog Scale (VAS) for post-surgical pain, minimum value=0, maximum value=10, higher score means worse outcome
Change in Gingival Margin (GM) From Baseline to 12 Months	12 months after baseline	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.
Change in Root Dentin Hypersensitivity (RDH) From Baseline to 12 Months	12 months after baseline	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.
Change in Plaque Index (PI) From Baseline to 12 Months	12 months after baseline	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.
Change in Bleeding on Probing (BoP) From Baseline to 12 Months	12 months after baseline	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.

Countries

United States

Participant flow

Recruitment details

The recruitment was terminated prematurely.

Participants by arm

Arm	Count
Emdogain Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	18
Periodontal Surgery Periodontal surgery alone Periodontal surgery: Periodontal surgery alone	17
Total	35

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Protocol Violation	3	2
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Emdogain	Periodontal Surgery	Total
Age, Continuous	50.3 years STANDARD_DEVIATION 14	53.9 years STANDARD_DEVIATION 13.2	52.4 years STANDARD_DEVIATION 13.2
Region of Enrollment Germany	10 participants	7 participants	17 participants
Region of Enrollment Switzerland	3 participants	3 participants	6 participants
Region of Enrollment United States	5 participants	7 participants	12 participants
Sex: Female, Male Female	8 Participants	14 Participants	22 Participants
Sex: Female, Male Male	10 Participants	3 Participants	13 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	1 / 18	1 / 17
serious Total, serious adverse events	0 / 18	0 / 17

Outcome results

Primary

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.

Time frame: 12 Months

Arm	Measure	Value (MEAN)	Dispersion
Emdogain	Clinical Attachment Level	-2.91 mm	Standard Deviation 1.3
Periodontal Surgery	Clinical Attachment Level	-2.08 mm	Standard Deviation 1.32

Secondary

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.