The aim of this study is to compare the effectiveness in periodontal regeneration of cross-linked hyaluronic acid at 1.8% (Hyadent BG®) with enamel matrix derivative (Emdogain®) in periodontal bone defects evaluating their clinical and radiographic variables.
A high molecular weight polysaccharide, hyaluronic acid, also known as hyaluronan or hyaluronate, has recently been studied as a promising mediator for periodontal regeneration. It has a significant role in mineralized and non-mineralized periodontal tissues for the functioning of its extracellular matrices. It has a multifunctional role in periodontics including the stimulation of cell migration, proliferation and differentiation and the acceleration of wound healing by stimulating angiogenesis. It is used in surgical procedures due to its osteoinductive potential. HA is a key element in soft periodontal tissues, the gingiva and periodontal ligament, and in hard tissue, such as alveolar bone and cementum. It has many structural and physiological functions within these tissues. This research proposes two experimental groups to whom one of them will be applied cross-linked hyaluronic acid at 1.8% and another group with enamel matrix derivative, and a control group. The investigator's hypothesis is that the hyaluronic acid shows potential for periodontal regeneration when evaluating its clinical and radiographic variables and when compared with the use of Enamel matrix derivative.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Regenerative periodontal therapy + Cross-linked hyaluronic acid 1.8%: * The modified minimal invasive surgical technique, described by Cortellini 2011, will be used to raise the interdental papilla over the bone defect. * Measurement of bone defect with a 0.5mm periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Illinois, USA) to characterize the defect anatomy. * Inflammatory tissue will be debrided and the root carefully planed using Gracey curettes. * The site will be washed with physiologic sterile solution, dried and the root wil be conditioned with 24% Ethylenediamine tetraacetic acid (EDTA) for two minutes, then the defect area will be carefully rinsed with sterile saline to remove any residual EDTA. * Application of Hyadent BG® 1,8% filling the bone defect from the bottom upwards in the test group. * Single internal modified mattress suture (5/0 Vicryl, Ethicon). * Sutures will be removed after two weeks.
Regenerative periodontal therapy + Enamel matrix proteins: * The modified minimal invasive surgical technique, described by Cortellini 2011, will be used to raise the interdental papilla over the bone defect. * Measurement of bone defect with a 0.5mm periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Illinois, USA) to characterize the defect anatomy. * Inflammatory tissue will be debrided and the root carefully planed using Gracey curettes. * The site will be washed with physiologic sterile solution, dried and the root wil be conditioned with 24% Ethylenediamine tetraacetic acid (EDTA) for two minutes, then the defect area will be carefully rinsed with sterile saline to remove any residual EDTA. * Application of Emdogain® filling the bone defect from the bottom upwards in the active comparator group. * Single internal modified mattress suture (5/0 Vicryl, Ethicon). * Sutures will be removed after two weeks.
Clinical measure: Clinical attachment loss (CAL). Changes will be assessed at 3 time points.
It is defined as the distance in millimeters between CEJ and the end of the periodontal pocket. The calculation of the depth of the pocket + gingival recession or pocket depth - gingival hyperplasia will be carried out.
Time frame: 1. Baseline, 2. Reevaluation (60 days after root debridement), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
Radiographic measure: Cemento-enamel junction (A1)
• The cemento-enamel junction (CEJ)of the tooth involved in the intrabony defect.
Time frame: 1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).
Radiographic measure: B1
The most coronal position of the alveolar bone crest of the intrabony defect when it touches the root surface of the adjacent tooth before treatment (the top of the crest).
Time frame: 1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).
Radiographic measure: D1
The most apical extension of the intrabony destruction where the periodontal ligament space still retained its normal width before treatment (the bottom of the defect).
Time frame: 1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).
Clinical measure: Probing pocket depth (PPD). Changes will be assessed at 3 time points.
The probing depth will be measured in six areas (disto-buccal, mediate-vestibular, mesio-buccal, disto-palatal, mid-palatal, and mesio-palatal) of each tooth with a Williams PQ-OW 208 396 probe. It will be use with a pressure of 20 grams that is equivalent to the pressure of dropping the weight of the probe without exerting additional pressure.
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Time frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
Clinical measure: Gingival recession (GR). Changes will be assessed at 3 time points.
The "Full mouth bleeding score" (FMBS) will be calculated based on scores of 0 (no bleeding) or 1 (bleeding) after probing depths are checked. The usual thing is to measure 4 points for each tooth, but we have modified the index and we value 6 points per tooth (disto-buccal, mid-buccal, mesio-buccal, disto-palatal, mid-palatal and mesio-palatal). We consider that the score is 1 when we see a red dot in the% bleeding diagram of the periodontogram and 0 when we see the blank box.
Time frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
Clinical measure: Tooth mobility (TM) Miller (1950). Changes will be assessed at 3 time points.
* Class I: Mobility up to 1 mm in the horizontal direction. * Class II: Mobility greater than 1 mm in the horizontal direction. * Class III: Excessive movement in both horizontal and vertical directions.
Time frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
Clinical measure: Furcation involvement: Hamp (1975). Changes will be assessed at 3 time points.
The plaque will be quantified as follows: * Score 0 = no plaque * Score 1 = A film of plaque adhered to the free gingival margin and the adjacent area of the tooth. The plaque can be seen in situ only after the application of a plaque revealer or by using the probe on the surface of the tooth. * Score 2 = moderate accumulation of soft deposits in the pocket, tooth or gingival margin, which can be seen with our eyes. * Puntuación 3 = Abundance of soft material inside the bag and / or on the tooth and the gingival margin. The evaluation will be carried out in 4 points per tooth (disto-buccal, mesio-buccal, disto-palatal, mesio-palatal).
Time frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
Clinical measure: Plaque Index (Sillness y Löe 1964). Changes will be assessed at 3 time points.
The plaque will be quantified as follows: * Score 0 = no plaque * Score 1 = A film of plaque adhered to the free gingival margin and the adjacent area of the tooth. The plaque can be seen in situ only after the application of a plaque revealer or by using the probe on the surface of the tooth. * Score 2 = moderate accumulation of soft deposits in the pocket, tooth or gingival margin, which can be seen with our eyes. * Puntuación 3 = Abundance of soft material inside the bag and / or on the tooth and the gingival margin. The evaluation will be carried out in 4 points per tooth (disto-buccal, mesio-buccal, disto-palatal, mesio-palatal).
Time frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).