]>
IRCT20230117057150N1 IRCT 2023-01-24 Babol University of Medical Sciences the effect of flapless surgery on bone regeneration following immediate implant placement ؛ the effect of open flap surgery on bone regeneration following immediate implant placement Evaluation of the amount of buccal bone plate regeneration using CBCT following immediate implant placement in dental sockets with buccal wall dehiscence by two surgical techniques: open flap and flapless along with GBR 2023-02-20 anticipated 24 Complete https://irct.ir/trial/68083 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly divided into two groups: randomization will be done using the random number generation option of the kitset.ir website, so that the first half will be in the flapless group and the second half will be in the open flap group, Blinding description: CBCT images are blindly analyzed by a radiologist in order to evaluate the regeneration of dental socket buccal bone plate 6 months after the intervention. N/A Dehiscence of buccal wall of dental socket. Intervention 1: Intervention group: flapless surgery technique, The surgical protocol will require atraumatic extraction of the tooth without a flap. Dental debridement and clinical examination will be performed to assess the lack of labial plate and ensure the presence of sufficient interproximal bone. Osteotomy is performed with a palatal inclination to place the implant. In this study, tapered implant (DIO) will be used. After planting the implant, a pocket remains relative to the buccal plate. A collagen membrane (cenoderm-kish-iran) is prepared in the shape of an ice cream cone to reconstruct the plate. The membrane is placed inside the remaining buccal bone plate, and the bone graft (FDBA) with a particle size of 500-1000 micrometers, 0.25-0.5 cc (CenoBone-Kish-Iran) is placed in the implant gap and buccal contour. After socket filling with Bone graft, the coronal part of the membrane is folded to cover the socket, and a horizontal mattress suture is placed on the palate to stabilize the membrane. CBCT images using a planmeca device (finland) are prepared before surgery (T0) and 6 months (T1) after recovery in order to evaluate the amount of buccal bone plate regeneration. Intervention 2: Intervention group: open flap surgery technique, In this group, after tooth extraction, first a crestal incision and two vertical incisions are made, and the flap is raised in full thickness until 2 to 3 mm of the buccal bone is exposed. For greater flexibility of the flap and the possibility of closing the surgical site, a periosteal incision is given. The steps of implantation, the type of implant and the type of bone graft will be similar to the first group. CBCT images using a planmeca device (finland) are prepared before surgery (T0) and 6 months (T1) after recovery in order to evaluate the amount of buccal bone plate regeneration. 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 further information.
public Dr. Majid Fereyduni
Nurse Ave، University Square، Morad Beg Town
Babol Iran (Islamic Republic of) 4717643633 +98 11 3229 1408 golpasha@yahoo.com Babol University of Medical Sciences scientific Dr. Majid Fereyduni
Nurse Ave, University Square, Morad Beg Town
Babol Iran (Islamic Republic of) 4717643633 +98 11 3229 1408 golpasha@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) People with hopeless anterior teeth of the maxilla with buccal wall dehiscence 18 years no limit Both The presence of periodontal disease in hopeless anterior teeth of the maxilla People with medical and psychiatric problems for whom surgery is contraindicated Smokers and alcoholism pregnant women People with bruxism or other parafunctional dental habits K08.9 Disorders of teeth and supporting structures، unspecified Treatment - Surgery Treatment - Surgery Intervention group: flapless surgery technique, The surgical protocol will require atraumatic extraction of the tooth without a flap. Dental debridement and clinical examination will be performed to assess the lack of labial plate and ensure the presence of sufficient interproximal bone. Osteotomy is performed with a palatal inclination to place the implant. In this study, tapered implant (DIO) will be used. After planting the implant, a pocket remains relative to the buccal plate. A collagen membrane (cenoderm-kish-iran) is prepared in the shape of an ice cream cone to reconstruct the plate. The membrane is placed inside the remaining buccal bone plate, and the bone graft (FDBA) with a particle size of 500-1000 micrometers, 0.25-0.5 cc (CenoBone-Kish-Iran) is placed in the implant gap and buccal contour. After socket filling with Bone graft, the coronal part of the membrane is folded to cover the socket, and a horizontal mattress suture is placed on the palate to stabilize the membrane. CBCT images using a planmeca device (finland) are prepared before surgery (T0) and 6 months (T1) after recovery in order to evaluate the amount of buccal bone plate regeneration. Intervention group: open flap surgery technique, In this group, after tooth extraction, first a crestal incision and two vertical incisions are made, and the flap is raised in full thickness until 2 to 3 mm of the buccal bone is exposed. For greater flexibility of the flap and the possibility of closing the surgical site, a periosteal incision is given. The steps of implantation, the type of implant and the type of bone graft will be similar to the first group. CBCT images using a planmeca device (finland) are prepared before surgery (T0) and 6 months (T1) after recovery in order to evaluate the amount of buccal bone plate regeneration. Buccal bone height: dependent variable, quantitative continuous; The method of measurement is from the most coronal part of the remaining bone crest to the floor of the nasal cavity or maxillary sinus. Timepoint: CBCT time before surgery and 6 months after surgery. Method of measurement: Buccal bone height: The method of measurement in CBCT images is from the most coronal part of the remaining bone crest to the floor of the nasal cavity or maxillary sinus in millimeters. Buccal bone thickness: dependent variable, quantitative continuous; The method of measurement is from the apical millimeter of the crest of the buccal bone. Timepoint: CBCT time before surgery and 6 months after surgery. Method of measurement: The thickness of the buccal bone: the method of measurement is from the apical millimeter of the crest of the buccal bone in millimeters. Babol University of Medical Sciences Approved 2023-01-09 Research Ethics Committees of Babol University of Medical Sciences ganj afrouz street Babol Mazandaran Iran (Islamic Republic of)