Trial Outcomes & Findings for Emdogain Minimally Invasive Surgical Technique (NCT NCT02551770)

NCT ID: NCT02551770

Last Updated: 2019-10-17

Results Overview

CAL will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of CAL from baseline measurements at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of CAL for test and control treatment arms.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 51 participants
• Primary outcome timeframe: Baseline and 12 Month Follow-Up Visit
• Results posted on: 2019-10-17

Participant Flow

Oversight. 1 extra patient was enrolled.

Unit of analysis: Study Teeth

Participant milestones

Measure	Test (With Emdogain) Scaling and root planing with Emdogain Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw. Emdogain application: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw	Control (Without Emdogain) Scaling and root planing without Emdogain Scaling and root planing without Emdogain: Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.
Overall Study STARTED	51 167	51 170
Overall Study COMPLETED	48 162	48 162
Overall Study NOT COMPLETED	3 5	3 8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Emdogain Minimally Invasive Surgical Technique

Baseline characteristics by cohort

Measure	All Participants n=51 Participants Participants assigned to receive both interventions (i.e., control and test) in different quadrants of the jaw. \- Test Treatment (Scaling and root planing with Emdogain): Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw. Emdogain application: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw. \- Control Treatment (Scaling and root planing): Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) to treat one contra-lateral quadrant in subject's jaw.
Age, Customized <18	0 Participants n=5 Participants
Age, Customized 18-85	51 Participants n=5 Participants
Age, Customized >85	0 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants
Region of Enrollment Germany	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 Month Follow-Up Visit

Population: The ITT data set with imputation of missing values (five CAL values were missing at 12 month follow-up and were replaced with values from 9 month follow-up).

CAL will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of CAL from baseline measurements at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of CAL for test and control treatment arms.

Outcome measures

Measure	Test (With Emdogain) n=49 Participants Scaling and root planing with Emdogain Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw. Emdogain application: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw	Control (Without Emdogain) n=49 Participants Scaling and root planing without Emdogain Scaling and root planing without Emdogain: Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.
Change in Clinical Attachment Levels (CAL)	-2.2 mm Standard Deviation 1.5	-2.1 mm Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline and 12 Month Follow-Up Visit

Population: from the ITT dataset. Missing data was not entered.

GM will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of GM from baseline at surgery to 12-months-post surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of GM for test and control treatment arms.

Outcome measures

Measure	Test (With Emdogain) n=47 Participants Scaling and root planing with Emdogain Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw. Emdogain application: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw	Control (Without Emdogain) n=46 Participants Scaling and root planing without Emdogain Scaling and root planing without Emdogain: Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.
Change in Gingival Margin (GM)	-.3 mm Standard Deviation .9	-.2 mm Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline and 12 Month Follow-Up Visit

Population: ITT dataset.

PPD will be measured in millimeters on the study teeth in 6 locations. Outcome is mean change of PPD from baseline at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth at baseline. Analysis will compare the mean change of PPD for test and control treatment arms.

Outcome measures

Measure	Test (With Emdogain) n=47 Participants Scaling and root planing with Emdogain Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw. Emdogain application: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw	Control (Without Emdogain) n=47 Participants Scaling and root planing without Emdogain Scaling and root planing without Emdogain: Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.
Change in Pocket Probing Depth (PPD)	-2.4 mm Standard Deviation 1.3	-2.3 mm Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline and 12 Month Follow-Up Visit

Population: ITT data set.

FMPS will be calculated based on the number of tooth surfaces with plaque over the total number of tooth surfaces x 100. The value is presented as a percent. The difference in FMPS between 12 months and baseline will be determined.

Outcome measures

Measure	Test (With Emdogain) n=668 Tooth surfaces Scaling and root planing with Emdogain Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw. Emdogain application: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw	Control (Without Emdogain) n=684 Tooth surfaces Scaling and root planing without Emdogain Scaling and root planing without Emdogain: Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.
Change in Full Mouth Plaque Score (FMPS) Baseline	54.34 Full Mouth Plaque Score	55.17 Full Mouth Plaque Score
Change in Full Mouth Plaque Score (FMPS) 12 Month Follow Up	35.03 Full Mouth Plaque Score	31.58 Full Mouth Plaque Score

SECONDARY outcome

Timeframe: Baseline and 12 Month Follow-Up Visit

Population: ITT data set.

For the categorical variable BoP, the frequency of bleeding (present or absent) will be counted (absolute and in percent) over all measured sites around the identified study teeth for each treatment group. The results will be compared between the 12-month follow-up and baseline.

Outcome measures

Measure	Test (With Emdogain) n=1002 Sites Scaling and root planing with Emdogain Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw. Emdogain application: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw	Control (Without Emdogain) n=1026 Sites Scaling and root planing without Emdogain Scaling and root planing without Emdogain: Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.
Change in Bleeding on Probing (BoP) 12 month sites with bleeding	172 Sites	223 Sites
Change in Bleeding on Probing (BoP) Baseline sites with bleeding	547 Sites	576 Sites
Change in Bleeding on Probing (BoP) Baseline sites without bleeding	455 Sites	450 Sites
Change in Bleeding on Probing (BoP) 12 month sites without bleeding	797 Sites	743 Sites

SECONDARY outcome

Timeframe: Baseline and 12 Month Follow-Up Visit

Population: ITT data set study teeth. Baseline collected at either visit 1 or visit 2 based on different versions of CIP.

Presence of root dentin hypersensitivity will be recorded as "none" (no reaction from the subject), "mild" (sensible with no pain), "moderate" (sensible with slight pain), or "severe" (sensible with pain that persists for a while) after a conventional air blast is applied to the study tooth. Changes in the frequency of categories will be determined and compared between the two treatment arms. An improvement is defined as a decreased reaction (for example, severe to mild), a deterioration is defined as increased reaction (for example, none to moderate), and unchanged is no change to reaction (for example, mild to mild).

Outcome measures

Measure	Test (With Emdogain) n=159 Study Teeth Scaling and root planing with Emdogain Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw. Emdogain application: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw	Control (Without Emdogain) n=156 Study Teeth Scaling and root planing without Emdogain Scaling and root planing without Emdogain: Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.
Change in Root Dentin Hypersensitivity Improvement in Root Dentin Hypersensitivity	44 Study Teeth	37 Study Teeth
Change in Root Dentin Hypersensitivity Deterioration in Root Dentin Hypersensitivity	8 Study Teeth	13 Study Teeth
Change in Root Dentin Hypersensitivity Unchanged Root Dentin Hypersensitivity	107 Study Teeth	106 Study Teeth

SECONDARY outcome

Timeframe: 1-2 days post surgery, 1 week post surgery, and 2 weeks post surgery

Population: ITT dataset.

Post-surgical pain will be measured on a 100 millimeter visual analog scale. The range is 0 (no pain) to 99 (nearly maximum pain). The lower the value, the better the outcome. The subjects will be instructed to mark their level of pain on a line for both the test quadrant and the control quadrant. The average change in pain level will be determined and compared between the two arms.

Outcome measures

Measure	Test (With Emdogain) n=49 Participants Scaling and root planing with Emdogain Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw. Emdogain application: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw	Control (Without Emdogain) n=49 Participants Scaling and root planing without Emdogain Scaling and root planing without Emdogain: Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.
Change in Post-surgical Pain Pain Level 1-2 days post sx.	14.3 mm Standard Deviation 22.6	12.9 mm Standard Deviation 20.9
Change in Post-surgical Pain Pain level 1 week post sx	9.8 mm Standard Deviation 20.6	8.1 mm Standard Deviation 19.6
Change in Post-surgical Pain Pain Level 2 weeks post sx.	6.0 mm Standard Deviation 16.6	5.0 mm Standard Deviation 13.8

Adverse Events

All Participants

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants n=51 participants at risk All Participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer diagnosis	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.

Other adverse events

Measure	All Participants n=51 participants at risk All Participants
Infections and infestations Sinus Infection	3.9% 2/51 • Number of events 2 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Extensive tooth decay	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
Respiratory, thoracic and mediastinal disorders Cold/Flu	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Mild discomfort when chewing	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Retrained bony sequestrum	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Generalized sensation of burning mouth	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Itching skin reaction gum	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
Skin and subcutaneous tissue disorders Itching skin reaction neck area, external	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Fracture of Veneer #21	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Hematoma	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Tooth fracture #23	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Apical periodontitis	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Abscess on extracted tooth #20	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Bleeding and mobility at #24 and 28	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Loosening of bridge	2.0% 1/51 • Number of events 4 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Sensitivity to cold teeth # 4,5,7 and 9-11	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Unclear tooth complaint #5 and #6	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Restoration prosthetic problem	2.0% 1/51 • Number of events 2 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Hypersensitivity to pain # 22 and 25-28	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.
General disorders Sensitivity to warmth and cold # 19,21,22,25,27-29	2.0% 1/51 • Number of events 1 • Up to 12 months. All participants received both interventions and adverse events were not collected with regard to separate intervention.

Additional Information

Dr. Manfred Klasser

GWD Consult

Phone: +49 6108 825 65 20

Email: manfred.klasser@gwd-consult.de

Results disclosure agreements

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

Restriction type: GT60