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IRCT20211106052978N1 IRCT 2021-12-02 Islamic Azad University Effectiveness of hyaluronic acid in coronally advanced flap(CAF) Effectiveness of hyaluronic acid application in coronally advanced flap(CAF) technique in root coverage 2021-11-18 anticipated 13 Complete https://irct.ir/trial/59975 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, during surgery, using the coin toss method, it is determined which side of the case group and which side of the control group. In this way, the side of the control heads and the side of the case tails were considered, and after dropping the coin on the case side of hyaluronic acid gel, and on the control side, surgery without hyaluronic acid gel was performed, Blinding description: In this study, an examiner who measures clinical parameters and reviews and interprets the results, and participants are unaware of which side is the control and which side is the case. Participants (patients) did not know which side of the surgical site used the hyaluronic acid gel. N/A gingival recession. Intervention 1: For this research, the trapezoidal CAF technique based on Zucchelli method will be used. (60) After local anesthesia with a Persocaine-E 2% cartridge (lidocaine hydrochloride 20 mg, epinephrine 12.5 micrograms, Darupakhsh Co., Iran) first the root coverage line (CEJ) is determined and then the amount of flap coronation (Y) will be calculated using the opposite formula: Y = RD1mm (this 1mm is used to compensate for contraction after surgery.) Then this distance from the tip of the anatomical papilla to the apical is marked. The location of the horizontal incision will be epicoronally. The horizontal incisions will extend mesiodistally from the margin of gingival resorption to 3 mm and at the end of each of them will be a vertical incision that is about 3-4 mm inwards. The alveolar mucosa expands. After determining the boundaries of the incisions, the flap is lifted as described below. , Get up. The apical margin margin of the gingival resorption is then lifted full-thickness by a narrow alveolus up to 3 mm more apical than the bone crest (to provide sufficient volume of tissue to cover the root). And the rest of the areas that are apical to the bone area are split-ticked to allow the flap to coronalize. Doing this requires two different cuts, which include: 1. Deep incision: to separate the muscle connections from the periosteum (with a razor parallel to the bone surface) 2. Superficial incision: To separate the muscle connections from the alveolar mucosa (by a razor parallel to the mucosal surface), the anatomical papillae are then de-epithelialized, followed by a gentle root planning with a gracy court (# 5-6, hu-friedy) is performed in the area of ​​the area that was previously the root of the exposure, and after determining which side of the case and which side is the control; Crossed linked-hyaluronic acid (Hyaluronic acid, Hyadent BG, Bioscience, Germany) was used for the case group after CAF technique to cover the root surface before suturing. HA as a cartridge It is disposable and is inserted into the syringe, completely covering the root surface according to the factory instructions, and finally the flap becomes coronal at 1mm beyond the CEJ. The stitches are then sewn with a 50 nylon thread as described. After coronalizing the flap, the first suture is sutured at the apical end of the vertical mesial incision as a simple discontinuous periosteal suture in the coronal direction. The second suture is inserted at the end of the distal vertical incision in the same manner as described (these two sutures hold the flap in the desired coronal area). The vertical incisions are then made one by one with intermittent sutures from the apical to the coronal. Finally, the coronal part of the flap is closed with a sling suture so that first the needle takes the base of the mesial surgical papilla from the outside and after piercing the de-epithelialized anatomical papilla, it comes out from the palatal side, bypassing the tooth and It passes under the distal point of contact and again on the buccal side from the outside, it takes the base of the distal surgical papilla and after piercing the distal de-epithelialized anatomical papilla, it goes around the tooth again and passes under the mesial point of contact; Finally, it is tied at its entrance in Mesial. Intervention 2: Control group: For this research, the trapezoidal CAF technique based on Zucchelli method will be used. (60) After local anesthesia with a Persocaine-E 2% cartridge (lidocaine hydrochloride 20 mg, epinephrine 12.5 micrograms, Darupakhsh Co., Iran) first the root coverage line (CEJ) is determined and then the amount of flap coronation (Y) will be calculated using the opposite formula: Y = RD1mm (this 1mm is used to compensate for contraction after surgery.) Then this distance from the tip of the anatomical papilla to the apical is marked. The location of the horizontal incision will be epicoronally. The horizontal incisions will extend mesiodistally from the margin of gingival resorption to 3 mm and at the end of each of them will be a vertical incision that is about 3-4 mm inwards. The alveolar mucosa expands. After determining the boundaries of the incisions, the flap is lifted as described below. , Get up. The apical margin margin of the gingival resorption is then lifted full-thickness by a narrow alveolus up to 3 mm more apical than the bone crest (to provide sufficient volume of tissue to cover the root). And the rest of the areas that are apical to the bone area are split-ticked to allow the flap to coronalize. Doing this requires two different cuts, which include: 1. Deep incision: to separate the muscle connections from the periosteum (with a razor parallel to the bone surface) 2. Superficial incision: To separate the muscle connections from the alveolar mucosa (by a razor parallel to the mucosal surface), the anatomical papillae are then de-epithelialized, followed by a gentle root planning with a gracy court (# 5-6, hu-friedy) is performed in the area of ​​the area that was previously the root of the exposure, and finally the flap becomes coronal at 1mm beyond the CEJ. The stitches are then sewn with a 50 nylon thread as described. After coronalizing the flap, the first suture is sutured at the apical end of the vertical mesial incision as a simple discontinuous periosteal suture in the coronal direction. The second suture is inserted at the end of the distal vertical incision in the same manner as described (these two sutures hold the flap in the desired coronal area). The vertical incisions are then made one by one with intermittent sutures from the apical to the coronal. Finally, the coronal part of the flap is closed with a sling suture so that first the needle takes the base of the mesial surgical papilla from the outside and after piercing the de-epithelialized anatomical papilla, it comes out from the palatal side, bypassing the tooth and It passes under the distal point of contact and again on the buccal side from the outside, it takes the base of the distal surgical papilla and after piercing the distal de-epithelialized anatomical papilla, it goes around the tooth again and passes under the mesial point of contact; Finally, it is tied at its entrance in Mesial. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no more information
public Dr Saeed Sadatmansouri
9th Neyestan Pasdaran
Tehran Iran (Islamic Republic of) 19585175 +98 21 5796 8828 drsaeed_sadatmansouri@yahoo.com Islamic Azad University scientific Fatemeh Zolfaghari
9th Neyestan Pasdaran
Tehran Iran (Islamic Republic of) 19585175 +98 21 5766 8828 Dr.fateme.zolfaghari@gmail.com Islamic Azad University Iran (Islamic Republic of) Patients over 18 years of age. Patients with O'LEARY Index (plaque control index) less than 20%. Presence of at least two buccal gingival analyzes (depth of analysis ≥ 2mm) and no loss of interproximal joints (Miller class در) in the anterior regions of the maxilla and mandible (central, lateral, canine, first and second premolars) that have bilateral Cosmetic problems or dental allergies. The presence of CEJ is clear and recognizable. Has sufficient gingival thickness. (thick biotype) Minimum keratinized gingival width (at least 1 mm for shallow lesions and 2 mm for ≥ 5 mm lesions) Controls and cases patients in similar areas (type of jaw, type of tooth 18 years no limit Both Systemic disease pregnancy Active periodontal disease in the desired area. (Probe depth more than 4mm and BOP) Presence of veneer or restoration with edge on CEJ. History of periodontal surgery in the desired areas in the last 6 months. Smoking Long-term use of antibiotics in the last 6 months. Use of steroids and drugs affecting periodontal tissues K06.0 Gingival recession Treatment - Surgery Treatment - Surgery For this research, the trapezoidal CAF technique based on Zucchelli method will be used. (60) After local anesthesia with a Persocaine-E 2% cartridge (lidocaine hydrochloride 20 mg, epinephrine 12.5 micrograms, Darupakhsh Co., Iran) first the root coverage line (CEJ) is determined and then the amount of flap coronation (Y) will be calculated using the opposite formula: Y = RD1mm (this 1mm is used to compensate for contraction after surgery.) Then this distance from the tip of the anatomical papilla to the apical is marked. The location of the horizontal incision will be epicoronally. The horizontal incisions will extend mesiodistally from the margin of gingival resorption to 3 mm and at the end of each of them will be a vertical incision that is about 3-4 mm inwards. The alveolar mucosa expands. After determining the boundaries of the incisions, the flap is lifted as described below. , Get up. The apical margin margin of the gingival resorption is then lifted full-thickness by a narrow alveolus up to 3 mm more apical than the bone crest (to provide sufficient volume of tissue to cover the root). And the rest of the areas that are apical to the bone area are split-ticked to allow the flap to coronalize. Doing this requires two different cuts, which include: 1. Deep incision: to separate the muscle connections from the periosteum (with a razor parallel to the bone surface) 2. Superficial incision: To separate the muscle connections from the alveolar mucosa (by a razor parallel to the mucosal surface), the anatomical papillae are then de-epithelialized, followed by a gentle root planning with a gracy court (# 5-6, hu-friedy) is performed in the area of ​​the area that was previously the root of the exposure, and after determining which side of the case and which side is the control; Crossed linked-hyaluronic acid (Hyaluronic acid, Hyadent BG, Bioscience, Germany) was used for the case group after CAF technique to cover the root surface before suturing. HA as a cartridge It is disposable and is inserted into the syringe, completely covering the root surface according to the factory instructions, and finally the flap becomes coronal at 1mm beyond the CEJ. The stitches are then sewn with a 50 nylon thread as described. After coronalizing the flap, the first suture is sutured at the apical end of the vertical mesial incision as a simple discontinuous periosteal suture in the coronal direction. The second suture is inserted at the end of the distal vertical incision in the same manner as described (these two sutures hold the flap in the desired coronal area). The vertical incisions are then made one by one with intermittent sutures from the apical to the coronal. Finally, the coronal part of the flap is closed with a sling suture so that first the needle takes the base of the mesial surgical papilla from the outside and after piercing the de-epithelialized anatomical papilla, it comes out from the palatal side, bypassing the tooth and It passes under the distal point of contact and again on the buccal side from the outside, it takes the base of the distal surgical papilla and after piercing the distal de-epithelialized anatomical papilla, it goes around the tooth again and passes under the mesial point of contact; Finally, it is tied at its entrance in Mesial. Control group: For this research, the trapezoidal CAF technique based on Zucchelli method will be used. (60) After local anesthesia with a Persocaine-E 2% cartridge (lidocaine hydrochloride 20 mg, epinephrine 12.5 micrograms, Darupakhsh Co., Iran) first the root coverage line (CEJ) is determined and then the amount of flap coronation (Y) will be calculated using the opposite formula: Y = RD1mm (this 1mm is used to compensate for contraction after surgery.) Then this distance from the tip of the anatomical papilla to the apical is marked. The location of the horizontal incision will be epicoronally. The horizontal incisions will extend mesiodistally from the margin of gingival resorption to 3 mm and at the end of each of them will be a vertical incision that is about 3-4 mm inwards. The alveolar mucosa expands. After determining the boundaries of the incisions, the flap is lifted as described below. , Get up. The apical margin margin of the gingival resorption is then lifted full-thickness by a narrow alveolus up to 3 mm more apical than the bone crest (to provide sufficient volume of tissue to cover the root). And the rest of the areas that are apical to the bone area are split-ticked to allow the flap to coronalize. Doing this requires two different cuts, which include: 1. Deep incision: to separate the muscle connections from the periosteum (with a razor parallel to the bone surface) 2. Superficial incision: To separate the muscle connections from the alveolar mucosa (by a razor parallel to the mucosal surface), the anatomical papillae are then de-epithelialized, followed by a gentle root planning with a gracy court (# 5-6, hu-friedy) is performed in the area of ​​the area that was previously the root of the exposure, and finally the flap becomes coronal at 1mm beyond the CEJ. The stitches are then sewn with a 50 nylon thread as described. After coronalizing the flap, the first suture is sutured at the apical end of the vertical mesial incision as a simple discontinuous periosteal suture in the coronal direction. The second suture is inserted at the end of the distal vertical incision in the same manner as described (these two sutures hold the flap in the desired coronal area). The vertical incisions are then made one by one with intermittent sutures from the apical to the coronal. Finally, the coronal part of the flap is closed with a sling suture so that first the needle takes the base of the mesial surgical papilla from the outside and after piercing the de-epithelialized anatomical papilla, it comes out from the palatal side, bypassing the tooth and It passes under the distal point of contact and again on the buccal side from the outside, it takes the base of the distal surgical papilla and after piercing the distal de-epithelialized anatomical papilla, it goes around the tooth again and passes under the mesial point of contact; Finally, it is tied at its entrance in Mesial. Probe depth. Timepoint: base line / 6 weeks later / 3 months later / 6 months later. Method of measurement: Probing Pocket Depth (PPD): Measured in the midfacial area from the gingival margin to the end of the pocket by a periodontal probe. Recession depth. Timepoint: base line / 2 weeks later/ 6 weeks later / 3 months later / 6 months later. Method of measurement: Recession Depth (RD): In the midfacial area from the CEJ to the most apical margin of the gingival margin. Recession width. Timepoint: base line / 2 weeks later/ 6 weeks later / 3 months later / 6 months later. Method of measurement: Recession Width (RW): The width of the gingival resorption is measured at the CEJ. Width of keratinized tissue. Timepoint: base line / 2 weeks later/ 6 weeks later / 3 months later / 6 months later. Method of measurement: . The width of keratinized tissue, measured from the gingival margin to the MGJ, is measured in the medial region. Mean root coverage. Timepoint: base line / 6 weeks later / 3 months later / 6 months later. Method of measurement: Mean Root Coverage (MRC): The average percentage of root surface previously It was exposed but is now covered. Based on this formula, it is calculated: (Depth of initial analysis  RDi and depth of analysis day  RDp () (RDi-RDp) / RDi × 100. Complete root coverage. Timepoint: base line / 6 weeks later / 3 months later / 6 months later. Method of measurement: Complete Root Coverage (CRC): Percentage of patients whose root surface is completely covered. And is calculated based on this formula: (number of specimens that received full root cover  NCRC and total number of specimens  NT) NCRC / NT × 100. Clinical attachment level. Timepoint: base line / 6 weeks later / 3 months later / 6 months later. Method of measurement: Clinical Attachment Level (CAL): In the midfacial areas of RD + PPD. Islamic Azad University Approved 2020-05-26 Ethics Committee of the School of Dentistry, Tehran Azad University of Medical Sciences 9th neyestan pasdaran tehran Tehran Iran (Islamic Republic of)