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IRCT20211115053065N1 IRCT 2022-01-01 Islamic Azad University Effect of the xenografting on the buccal soft tissue dimensions of the immediate implant Dimensional changes of soft tissue following immediate flapless implant placement and provisionalization with or without xenograft: A Randomized Clinical Trial 2022-01-21 anticipated 34 Complete https://irct.ir/trial/60226 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: the selected patients will be divided into two groups by the Balanced block randomization method with a size of 4 blocks. Participants will be randomly allocated (1:1) to group 1 (with bone graft) and group 2 (without bone graft). The randomization sequence will be generated by an independent investigator using computer software ( www.randomization.com ). Balanced Blocked randomization will be used, with a block size of 4. The surgeon will open sequentially numbered, sealed envelopes only after the implants will be inserted at the day of surgeries. Although the surgeon will be aware of the allocated arm, soft tissue dimentional changes outcome assessor will be kept blinded to the allocation, Blinding description: the selected patients are unaware of their assignment to the case group (performing xenograft bone graft) or the control group (not performing xenograft bone grafting). N/A Severe gingival resorption after implant treatment in the maxillary cosmetic area. Intervention 1: Intervention group: After extracting the specified tooth, the patients received a Dentium brand implant made in South Korea, the gap between the sucket buccal wall and the implant surface will then be filled with US-made SigmaGraft-InterOss xenograft material. After placing the implant, the surgeon takes an impression of the implant, opposing arch impression, and jaw records. on both implant and bone graft, the healing abutment is put. it will be removed 2 weeks after placing the implant, and provisionalization will be replaced. Intervention 2: Control group: After extracting the specified tooth, the patients received a Dentium brand implant made in South Korea, and then the gap between the sucket buccal walll and the surface of the implant will be left empty. After implant placement, the surgeon takes an impression of the implant, opposing arch impression, and jaw records. on the implant, the healing abutment is put. it will be removed 2 weeks after placing the implant, and provisionalization will be replaced. 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 At the discretion of the researcher, the information of the participants will be published
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Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Islamic Azad University of Tehran, No.4, 9 Neyestan Ave, Pasdaran Blv, Tehran, Iran
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2256 4571 taherehbitaraf@yahoo.com Islamic Azad University scientific dr. Tahereh Bitaraf
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Islamic Azad University of Tehran, No.4, 9 Neyestan Ave, Pasdaran Blv, Tehran, Iran
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2256 4571 taherehbitaraf@yahoo.com Islamic Azad University Iran (Islamic Republic of) Patients prone to extract one of the maxillary anterior teeth in the cosmetic zone (number of teeth 14-24) and placement of immediate implants with provisionalization Continuation of the buccal wall bone of the extracted tooth socket with sufficient thickness after tooth extraction Existence of more than 2 mm gap between the implant and the socket buccal wall no limit no limit Both Periodontal disease Presence of systemic or local diseases that are opposed to implant placement (diabetes, hyperthyroidism, hyperparathyroidism, and osteoporosis) Pregnancy Cigarette and drug addiction Presence of acute infection at the implant site Patient undergoing radiotherapy Use of drugs that disrupt bone and gingival tissue repair Patients with parafunctional habits such as Bruxism or Clenching Treatment - Surgery Treatment - Surgery Intervention group: After extracting the specified tooth, the patients received a Dentium brand implant made in South Korea, the gap between the sucket buccal wall and the implant surface will then be filled with US-made SigmaGraft-InterOss xenograft material. After placing the implant, the surgeon takes an impression of the implant, opposing arch impression, and jaw records. on both implant and bone graft, the healing abutment is put. it will be removed 2 weeks after placing the implant, and provisionalization will be replaced. Control group: After extracting the specified tooth, the patients received a Dentium brand implant made in South Korea, and then the gap between the sucket buccal walll and the surface of the implant will be left empty. After implant placement, the surgeon takes an impression of the implant, opposing arch impression, and jaw records. on the implant, the healing abutment is put. it will be removed 2 weeks after placing the implant, and provisionalization will be replaced. Changes in the height of gingival tissue in the mesial, middle and distal areas of the buccal area of ​​the implant from the edge of the gingival margin. Timepoint: 2 weeks, 3 months and 6 months after implant placement. Method of measurement: Periodontal probe with the help of stent and 15-end file with Rabrastop. Changes in the thickness of the gingival soft tissue at intervals of 4 and 8 mm from the gingival margin in the mid buccal area of ​​the implant. Timepoint: 2 weeks, 3 months and 6 months after implant placement. Method of measurement: Periodontal probe with the help of stent and 15-end file with Rabrastop. Patient satisfaction with implant treatment. Timepoint: 2 weeks and 6 months after implant placement. Method of measurement: questionnaire. Islamic Azad University Approved 2021-11-13 Ethics committee of Azad University of Medical Sciences - Dental branch No.16, Nastaran av, second Golha st, Elahi st, Ayatollah kashani blv, Sadeghiye sq Tehran Tehran Iran (Islamic Republic of)