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Trial registered on ANZCTR


Registration number
ACTRN12619000062123
Ethics application status
Approved
Date submitted
9/01/2019
Date registered
17/01/2019
Date last updated
17/01/2019
Date data sharing statement initially provided
17/01/2019
Date results provided
17/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Enamel Matrix Derivative (EMDOGAIN) for the treatment of gum recession and dental implant infection/ridge management
Scientific title
Sub-epithelial Connective Tissue Graft with or without enamel matrix derivative for the treatment of multiple Class III-IV recessions in lower anterior teeth, assessment of collagen-stabilized anorganic bovine bone mineral with 10% collagen with or without enamel matrix derivative in ridge management and management of peri-implantitis.
Secondary ID [1] 297019 0
Nil
Universal Trial Number (UTN)
U1111-1226-4238
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gingival Recession 310999 0
Peri-implantitis 311000 0
Condition category
Condition code
Oral and Gastrointestinal 309651 309651 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All the surgical procedures will be perform by Dr. F Mercado, an experience Periodontist with 20 years of surgical experience doing these procedures.

For Periodontal Recession:

Treatment Test Group - Periodontal plastic surgery using connective tissue graft harvested from the palate combined with enamel matrix derivative application. The connective tissue or gum graft will be harvested from the palate by numbing the roof of the mouth. The superficial gum on the palate (1-1.5 mm) will be harvested. This usually takes around 20-30 minutes. The palate will be close by sutures that dissolves. This wound will normally be fully healed 1-2 weeks after the surgery. The patient will require 1-2 days of full rest at home with soft diet for a week. Each patient will have one carpule of emdogain (.35 ml standard car pule) which be applied on the root of the affected teeth before the gum graft is sutured onto the teeth.

Control Group - Connective Tissue Graft alone. This is the standard/conventional mode of treatment of gum recession.

For Peri-implantitis

Test: Bone xenograft with enamel matrix derivative after peri-implantitis surgical cleaning. Each patient will receive one block (250 mg Bio-Oss xenogarft) which is made by the company Geistlich, Switzerland. This bone graft with emdogain will be applied in the socket or applied around the implant after the implants are clean and removed of infection. This bone graft is deproteinised cow bone made in Switzerland and has been used in Australia for more than 10 years. The addition of emdogain on this group will check if the bone will be more stable after treatment.

Control: Bone xenograft alone after peri-implantitis surgical cleaning. This bone graft (without emdoagin) will be applied in the socket or applied around the implant after deep cleaning. This is the standard/conventional method of treatment at the moment.

The purpose of this study is to improve the clinical outcomes of peri-implantitis and bone level and periodontal recession treatment. To do this, Griffith University is conducting research into the reported beneficial effects of enamel matrix proteins which are reported to play a key role in the development of tooth-supporting tissues. Emdogain™, produced by the Swiss company ‘Straumann’, is a commercially available protein-based gel derived from the baby teeth of mini-pigs. The main active ingredient, amelogenin, is the same as that found humans and does not cause any allergic reaction.
The addition of Emdogain™ to current treatment protocols may therefore help improve the predictability and outcome of periodontal treatment procedures by inducing more natural bone formation in peri-implantitis affected areas and help promote the regeneration of new tissues including gum, bone and periodontal ligament required for the management of periodontal recession.
The clinical success of the addition of Emdogain™ to current treatment protocols will be determined by comparing the clinical measurements taken before and after periodontal surgeries.
Furthermore, samples collected during these visits will be assessed in the laboratory to help us determine what biological parameters may be responsible for any improvement in clinical outcomes.
Intervention code [1] 313299 0
Treatment: Surgery
Intervention code [2] 313300 0
Diagnosis / Prognosis
Comparator / control treatment
The study aims to recruit 100 referred patients for the study who will be allocated using sealed opaque envelope into one of four treatment groups:
1) Control: Peri-implantitis/Ridge Management - Bio-Oss only collagen only after deep cleaning treatment (25 patients). This is the conventional/standard method of treatment at the moment.
2) Test: Peri-implantitis/Ridge Management - Bio-Oss colagen immersed in Emdogain™ for 15 minutes after deep cleaning treatment (25 patients)
3) Control Group: Periodontal recession surgical treatment with Gum-graft only (25 patients) This is the conventional/standard method of treatment of gum recession at the moment.
4) Test Group: Periodontal recession surgical treatment with Gum-graft + Emdogain™ treatment application on the root surface (25 patients)

Eligible participants will be allocated to one of the four above-mentioned treatment groups before commencement of treatment. A unique identifier number will be assigned to each participant at this time to provide confidentiality throughout the study.
Control group
Active

Outcomes
Primary outcome [1] 318609 0
Recession measurement by mm using periodontal probe
Timepoint [1] 318609 0
The patients will be seen and gum measured every 6 months and the 12th month and 24th month measurements after treatment will be used for the analysis of the study.
Primary outcome [2] 318610 0
Radiographic measurement of bone level before and after surgical treatments.
Timepoint [2] 318610 0
X-rays will be taken at the 12th and 24th month review after the surgeries. This two x-rays will be compare to the one taken before the treatments are performed.
Primary outcome [3] 318655 0
pain level
Timepoint [3] 318655 0
1st and 2nd week after surgical treatment. The patient will be given a "pain sheet" after the treatment allotted. This pain sheet will be marked as a Visual analogue scale lined 1-10. The patient will put a vertical mark on a line marked 1-10 according to their degree of pain on the 2nd, 7th and 14th day after surgical treatments.These 3 pain scores will be analysed comparing Test and Control Groups.
Secondary outcome [1] 365596 0
Measurement of keratinized tissue - to be measured using periodontal probe every 6 months the patients are reviewed. The values measured on the 12th and 24th month will be analysed for the studies.
Timepoint [1] 365596 0
1st and 2nd year after surgical treatment
Secondary outcome [2] 365627 0
Bleeding gums
Timepoint [2] 365627 0
To be measured every 6 months of review using periodontal probe.
Secondary outcome [3] 365628 0
Tooth Retention
Timepoint [3] 365628 0
teeth to be counted on the 12th and 24th month of reviews
Secondary outcome [4] 365629 0
esthetic outcome
Timepoint [4] 365629 0
The patient will score 1-10, 1 worst to 10 best aesthetic scores around the surgical area graded on the 12th and 24th month of reviews

Eligibility
Key inclusion criteria
Systemically healthy stable/treated periodontal condition, non-smokers and aged between 18-70 years old, not pregnant or lactating, not taking any steroid medications, bisphosponates or anti-depressive medications.
Eligible participants will be allocated to one of the four above-mentioned treatment groups after an initial examination by a trained dental surgeon. A unique identifier number will be assigned to each participant at this time to provide confidentiality throughout the study.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Smokers, Patients with uncontrolled diabetes, those taking bisphosphonates, anti-depressants and antipsychotic medications, and pregnant or lactating females were excluded from the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization/Allocation: Sealed Opaque Envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using the opaque sealed envelope.

Whether "Test" or "Control" procedure will be performed will be dependent on the what is written on the envelope.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power analysis determined that a minimum sample size of 14 subjects per group was sufficient to detect a clinically significant mean difference in the primary parameter, new bone formation (NB%), of one standard deviation or more by Mann-Whitney U test at the 0.05 level with 88.5% power. Such that if the standard deviation for treated sites in the study population is 10% or less, then a population treatment mean difference of 10% or more would be considered clinically significant. With a potential drop-out rate of 20%, and a minimum of 80% of patients expected to complete the study, a total of 40 patients were enrolled, 20 in each group. Statistical analysis will be performed using commercially available software.|||| Mean values, standard deviations (mean ± SD) and percentages were calculated for each treatment at Patient and Tooth Level at the different time points. The significance of the difference within each group and between groups before and after treatment was analyzed using the student t-test. The primary outcome variables will be improvements in REC and KT. Secondary variables include improvements in CAL, PPD, Pain-VAS and patient centred-outcomes, percentage Mean Root Coverage (MRC) and number of teeth that achieved Complete Root Coverage (CRC). Data from the VAS scores and patient-centred outcomes scores were analyzed using Mann-Whitney tests. A p value of < .01 w will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/02/2013
Date of last participant enrolment
Anticipated
Actual
5/09/2016
Date of last data collection
Anticipated
Actual
10/12/2018
Sample size
Target
42
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12847 0
Nepean Private Hospital - Kingswood
Recruitment postcode(s) [1] 25323 0
2474 - Kingswood

Funding & Sponsors
Funding source category [1] 301587 0
Government body
Name [1] 301587 0
NHMRC
Country [1] 301587 0
Australia
Primary sponsor type
Individual
Name
Dr. Faustino Mercado
Address
Specialist Periodontal and Implant Centre
34 Castleragh St.
Penrith, NSW Australia 2750

Phd Student
at Griffith University
Oral Health Centre
Gold Coast Qld. 4222
Country
Australia
Secondary sponsor category [1] 301284 0
Individual
Name [1] 301284 0
Prof. Saso Ivanovski
Address [1] 301284 0
School of Dentistry , The University of Queensland
Level 7 Oral Health Centre
288 Herston Rd Qld 4006
Country [1] 301284 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302317 0
The Griffith University Human Research Ethics Committee
Ethics committee address [1] 302317 0
Ethics committee country [1] 302317 0
Australia
Date submitted for ethics approval [1] 302317 0
01/03/2012
Approval date [1] 302317 0
12/06/2012
Ethics approval number [1] 302317 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89798 0
Dr Faustino Mercado
Address 89798 0
Specialist Periodontal and Implant Centre
34 Castlereagh St
Penrith, NSW
2750
Country 89798 0
Australia
Phone 89798 0
+61 -2 47212888
Fax 89798 0
61-2-47321888
Email 89798 0
tinomerc@hotmail.com
Contact person for public queries
Name 89799 0
Faustino Mercado
Address 89799 0
Specialist Periodontal and Implant Centre
34 Castlereagh St
Penrith, NSW
2750
Country 89799 0
Australia
Phone 89799 0
+61 -2 47212888
Fax 89799 0
61-2-47321888
Email 89799 0
tinomerc@hotmail.com
Contact person for scientific queries
Name 89800 0
Saso Ivanovksi
Address 89800 0
University of Queensland
Oral Health Centre Queensland
Herston rd
Brisbane 4006
Country 89800 0
Australia
Phone 89800 0
+61 7 33658064
Fax 89800 0
Email 89800 0
s.ivanovski@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.