Phase 1: Screening After written informed consent has been obtained, the patient is
entered in the screening and enrolment log and in the patient identification log and
receives a patient identification number. An evaluation is then carried out by a
periodontist with a dental hygienist to determine whether the patient meets the study
inclusion criteria and none of the exclusion criteria and study specific information will
be collected. For excluded patients, the reason(s) for exclusion shall be documented.
Phase 2: Treatment After providing informed consent, screening completion and after
examination by a periodontist, study treatment will be performed only once the Plaque
Index (PI) of each screened patient will be <20%. This means that randomization and the
scaling phase (study treatment) will be only initiated when each individual patient was
compliant with the oral hygiene instructions and the PI (as measured with Staining
rondells red Directa, 4 surface plaque index, 1 rinsing 10 sec with 50 ml of water) was
recorded to be <20%.
Randomization to test or control-quadrants will be performed using statistical software
after full mouth scaling and root planing has taken place. Out of the four quadrants /
patient, two quadrants will be randomised to be treated according to standard care with
adjunctive Emdogain® FL. The remaining two quadrants will be treated as controls
(standard care; no adjunctive Emdogain® FL).
Following randomization, root planing and scaling will be performed by a calibrated
dental hygienist in all quadrants under local anaesthesia (with xylocaine adrenaline 2%).
First, an ultrasonic scaler (EMS) will be used and then manual scaling with LM-curettes
will be performed. The hygienist will scale each root surface until the root surface is
judged to be free of tartar. As part of standard care, this decision is made by the
calibrated dental hygienist based on tactile experience.
Pockets of 5mm to 9mm (PPD) will be treated in the study (both Test and Control
treatment). Test treatment: Emdogain® FL will be added to standard treatment i. e. Test
quadrants. PrefGel® will be applied on the root surface for 2 minutes, then rinsed away
with sterile saline solution for 30 seconds. The surface will be lightly dried using
gauze and airblow and then Emdogain® will be applied. The Emdogain® FL application will
be performed by the dental hygienist under the supervision of a periodontist. Control
treatment: pockets of 5mm to 9mm (PPD) will receive standard treatment (no addition of
Emdogain® FL) i. e. Control quadrants.
Additional teeth with PPD outside the range of 5mm to 9mm (PPD) may be present both in
Test and/or Control quadrants. Such teeth will be treated using standard care (no
Emdogain®) but they will not be included in study evaluations.
The patient will then be asked to rinse daily with an antiseptic mouth rinse twice a day
(FLUX-CHX chlorhexidine 0.12% solution) until 14 days following the treatment.
Antibiotics (e.g. penicillin V) may also be used in the presence of suppuration. The
patient will be instructed not to brush in the treated area for 7 days following the
treatment. Then only gentle brushing on buccal and lingual tooth surfaces using the roll
stroke method will be recommended. The patients will be instructed not to perform any
sulcular or interdental brushing before 2 weeks following the treatment.
Followed by individually planed healing controls and oral hygiene controls. (the number
of visits/follow-ups will be recorded and presented.
Phase 3: 6 months follow up Examination will be carried out by a periodontist (blinded)
at the six months follow up visit. Examination consists of periodontal assessments i. e.
PI, BoP and PPD.
Phase 4: 12 months follow up Examination will be carried out by a periodontist (blinded)
at the 12 months follow up visit. Examination consists of periodontal assessments (PI,
BoP, PPD) and X-rays.