Trial Outcomes & Findings for Effect of Postsurgical Systemic Doxycycline After Regenerative Periodontal Therapy (NCT NCT01030666)

Results Overview

Difference of PAL-V measurement at baseline and 6 months. PAL-V were measured to the nearest 0.5 mm using a straight manual periodontal probe (PCPUNC 15, Hu Friedy, Chicago, IL, USA). As reference for the PAL-V measurements, the cemento-enamel junction (CEJ) was used. If the CEJ is destroyed by a restoration (filling, crown) the margin of this restoration served as reference.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

61 participants

Primary outcome timeframe

Baseline to 6 months after surgery

Results posted on

2016-11-03

Participant Flow

From April 2007 to February 2009 all patients undergoing periodontal treatment at the Dept. of Periodontology, JWGUniversity Frankfurt and the Section of Periodontology, Department of Conservative Dentistry, University Hospital Heidelberg were screened for this study.

Participant milestones

Participant milestones
Measure	Doxycycline The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects	Placebo The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
Overall Study STARTED	28	33
Overall Study COMPLETED	25	31
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Doxycycline The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects	Placebo The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

Effect of Postsurgical Systemic Doxycycline After Regenerative Periodontal Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Doxycycline n=28 Participants The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects	Placebo n=33 Participants The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	32 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	54.2 years STANDARD_DEVIATION 10.3 • n=5 Participants	49.2 years STANDARD_DEVIATION 10 • n=7 Participants	51.5 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	23 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment Germany	28 participants n=5 Participants	33 participants n=7 Participants	61 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months after surgery

Population: per protocol analysis: all participants who attended the 6 months re-examination

Difference of PAL-V measurement at baseline and 6 months. PAL-V were measured to the nearest 0.5 mm using a straight manual periodontal probe (PCPUNC 15, Hu Friedy, Chicago, IL, USA). As reference for the PAL-V measurements, the cemento-enamel junction (CEJ) was used. If the CEJ is destroyed by a restoration (filling, crown) the margin of this restoration served as reference.

Outcome measures

Outcome measures
Measure	Doxycycline n=27 Participants The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects addionally to * modified/simplified papilla preservation flap; scaling * Prefgel/Emdogain * 0.12% chlorhexidine gluconate solution * Ibuprofen 400 mg (if necessary) * 1% chlorhexidine gluconate gel (if necessary)	Placebo n=31 Participants The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to * modified/simplified papilla preservation flap; scaling * Prefgel/Emdogain * 0.12% chlorhexidine gluconate solution * Ibuprofen 400 mg (if necessary) * 1% chlorhexidine gluconate gel (if necessary)
Vertical Clinical Attachment (PAL-V) Gain 6 Months After Surgery	3.11 mm Standard Deviation 1.50	3.40 mm Standard Deviation 1.79

SECONDARY outcome

Timeframe: Baseline to 12 months after surgery

Population: ITT population. Missing data due to losing to follow-up: last observation carried forward. Patients whose radiographs could not be analysed were excluded.

If the CEJ was destroyed by the restorative treatment the margin of the restoration was taken as landmark. BD is defined as most coronal point where the periodontal ligament space shows a continuous width. If no periodontal ligament space could be identified, the point where the projection of the alveolar crest (AC) crossed the root surface was taken as a landmark. If both structures could be identified at one defect, the point defined by the periodontal ligament was used as BD and the crossing of the silhouette of the alveolar crest with the root surface was defined as AC. If several bony contours could be identified, the most apical one that crossed the root was defined as the BD and the most coronal one as AC.

Outcome measures

Outcome measures
Measure	Doxycycline n=25 Participants The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects addionally to * modified/simplified papilla preservation flap; scaling * Prefgel/Emdogain * 0.12% chlorhexidine gluconate solution * Ibuprofen 400 mg (if necessary) * 1% chlorhexidine gluconate gel (if necessary)	Placebo n=30 Participants The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to * modified/simplified papilla preservation flap; scaling * Prefgel/Emdogain * 0.12% chlorhexidine gluconate solution * Ibuprofen 400 mg (if necessary) * 1% chlorhexidine gluconate gel (if necessary)
Radiographic Bony Fill 12 Months After Surgery (Reduction of Distance Cemento-enamel Junction [CEJ] to Bony Defect [BD])	1.09 mm Standard Deviation 2.7	1.51 mm Standard Deviation 2.89

Adverse Events

Doxycycline

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Doxycycline n=28 participants at risk The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects additionally to * modified/simplified papilla preservation flap; scaling * Prefgel/Emdogain * 0.12% chlorhexidine gluconate solution * Ibuprofen 400 mg (if necessary) * 1% chlorhexidine gluconate gel (if necessary)	Placebo n=33 participants at risk The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to * modified/simplified papilla preservation flap; scaling * Prefgel/Emdogain * 0.12% chlorhexidine gluconate solution * Ibuprofen 400 mg (if necessary) * 1% chlorhexidine gluconate gel (if necessary)
Nervous system disorders head ache	3.6% 1/28 • Number of events 1	12.1% 4/33 • Number of events 4
Ear and labyrinth disorders Nausea	10.7% 3/28 • Number of events 3	3.0% 1/33 • Number of events 1
General disorders tiredness	0.00% 0/28	6.1% 2/33 • Number of events 2
Gastrointestinal disorders tooth discomfort/pain	7.1% 2/28 • Number of events 2	0.00% 0/33
Skin and subcutaneous tissue disorders mucosal/skin lesions	7.1% 2/28 • Number of events 2	6.1% 2/33 • Number of events 2

Additional Information

Prof. Dr. Peter Eickholz

JWGUniversity

Phone: +496963015642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place