Trial Outcomes & Findings for Safety and Efficacy of Periodontal Surgery in Supra-alveolar-type Defects With or Without Straumann® Emdogain (NCT NCT01614925)

NCT ID: NCT01614925

Last Updated: 2020-12-01

Results Overview

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.

• Recruitment status: TERMINATED
• Target enrollment: 35 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2020-12-01

Participant Flow

The recruitment was terminated prematurely.

Participant milestones

Measure	Emdogain Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal Surgery Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Overall Study STARTED	18	17
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	Emdogain Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal Surgery Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Overall Study Withdrawal by Subject	1	0
Overall Study Protocol Violation	3	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Emdogain n=18 Participants Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal Surgery n=17 Participants Periodontal surgery alone Periodontal surgery: Periodontal surgery alone	Total n=35 Participants Total of all reporting groups
Age, Continuous	50.3 years STANDARD_DEVIATION 14.0 • n=5 Participants	53.9 years STANDARD_DEVIATION 13.2 • n=7 Participants	52.4 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	7 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Switzerland	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Germany	10 participants n=5 Participants	7 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Emdogain n=14 Participants Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal Surgery n=15 Participants Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Clinical Attachment Level	-2.91 mm Standard Deviation 1.3	-2.08 mm Standard Deviation 1.32

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Emdogain n=14 Participants Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal Surgery n=15 Participants Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Change in Gingival Margin (GM) From Baseline to 12 Months	-0.36 mm Standard Deviation 0.84	-0.27 mm Standard Deviation 1.53

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Emdogain n=14 Participants Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal Surgery n=15 Participants Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Change in Probing Pocket Depth (PPD) From Baseline to 12 Months	-2.93 mm Standard Deviation 1.44	-2.47 mm Standard Deviation 1.12

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Emdogain n=14 Participants Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal Surgery n=15 Participants Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Early Wound Healing Index (EHI) Assessment at 4 Weeks After Baseline	93 percentage of EHI category 1	100 percentage of EHI category 1

SECONDARY outcome

Timeframe: 4 weeks after baseline

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

Outcome measures

Measure	Emdogain n=14 Participants Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal Surgery n=15 Participants Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Comparison of Post-surgical Pain at 4 Weeks After Baseline	3.21 score on a scale Standard Deviation 9.39	3.47 score on a scale Standard Deviation 7.77

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Emdogain n=14 Participants Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal Surgery n=15 Participants Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Change in Bleeding on Probing (BoP) From Baseline to 12 Months	-36 percentage of BoP change	-13 percentage of BoP change

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Emdogain n=14 Participants Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal Surgery n=15 Participants Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Change in Root Dentin Hypersensitivity (RDH) From Baseline to 12 Months	-21.4 percentage of RDH change	-26.7 percentage of RDH change

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Emdogain n=14 Participants Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal Surgery n=15 Participants Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
Change in Plaque Index (PI) From Baseline to 12 Months	14.7 percentage of PI change	13.4 percentage of PI change

Adverse Events

Emdogain

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Periodontal Surgery

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Emdogain n=18 participants at risk Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain	Periodontal Surgery n=17 participants at risk Periodontal surgery alone Periodontal surgery: Periodontal surgery alone
General disorders Tooth hypersensitivity	0.00% 0/18 • 1 year	5.9% 1/17 • Number of events 1 • 1 year
General disorders Aphthous ulcer	5.6% 1/18 • Number of events 1 • 1 year	0.00% 0/17 • 1 year

Additional Information

Michel Mallaun

Straumann

Email: michel.mallaun@straumann.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place