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IRCT20251004067496N1 IRCT 2026-01-08 Kerman University of Medical Sciences Radiographic and clinical comparison of buccal gap filling methods in immediate implants. Radiographic and clinical comparison in 4 methods of filling the buccal gap of immediate dental implants using l-PRF،ePRF،Xenograft and without gap filling a randomized clinical trial 2025-11-22 anticipated 68 Complete https://irct.ir/trial/86824 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization is performed using software and a sealed envelope tool is used. Blinding is performed during the clinical data collection phase (soft tissue thickness measurement is performed by a dentist who is unaware of the grouping before surgery) and review of scan files and statistical analysis. The person taking the radiographic measurements is also unaware of the study grouping (only after 3 months of surgery is the xenograft group distinguished from the other groups due to the observation of bone particles on the radiograph). The participants in the study are not blinded, Blinding description: during the clinical data collection phase (soft tissue thickness measurement is performed by a dentist who is unaware of the grouping before surgery) and review of scan files and statistical analysis. The person taking the radiographic measurements is also unaware of the study grouping (only after 3 months of surgery is the xenograft group distinguished from the other groups due to the observation of bone particles on the radiograph). The participants in the study are not blinded. 3 People with systemic health conditions. Intervention 1: Intervention group: In the Xenograft group, cera bone with particle sizes of 150-1000 microns was hydrated in normal saline for 10 minutes and packed in the buccal gap area up to the bone crest area. Intervention 2: Intervention group: In the L-PRF group, after blood collection from the brachial artery, it is placed in 2 red 9 ml test tubes in a centrifuge at 2700 rpm for 12 minutes. After this time, the obtained L-PRF is separated from the red blood cells and packed by the special area in the PRF kit to produce L-PRF plug. Intervention 3: Intervention grouIn the buccal gap filling e-PRF group, after blood collection from the brachial artery in a 9 ml white test tube, it is centrifuged at 700 rpm for 8 minutes. After that, to prepare e-PRF, first 2 ml of the liquid was obtained. In the test tube, which is PPP (platelet poor plasma), it is aspirated using a 3 ml locking syringe And this syringe is placed in a heater for 10 minutes at 75°C to coagulate the proteins. During this time, the test tubes are placed in the refrigerator to prevent coagulation. After ten minutes, the syringes are removed from the heater and placed in the refrigerator to reach room temperature, and the centrifuge tubes are removed from the refrigerator and their plastic lids are opened and the L-PRF layer and buffy coat are aspirated using a locking syringe. The syringe containing the PPP is coagulated and PRF is connected using the syringe connector, and the contents of the syringe are mixed and injected into the buccal gap and packed up to the gingival margin using a condenser. Intervention 4: Control group: In the control group, no material is placed in the buccal gap. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Batool Mahmoodi
Shafa street, Kerman Dental School, Periodontology Department
Kerman Iran (Islamic Republic of) 7618759689 03432119021-4 batoolmahmoodi74@gmail.com Kerman University of Medical Sciences scientific Nazila Lashkarizadeh
Shafa street, Kerman Dental School, Periodontology Department
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9021 n_lashkarizadeh@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Systemically healthy patient Patients who are at least 18 years old The tooth socket must be type 1 (buccal soft tissue and buccal and lingual bone plates must be intact) Non-molar teeth that cannot be maintained Immediate implant placement (achieving initial stability of at least 35Ncm) is possible without moving the flap and there is sufficient intraocclusal space. It is possible to place an implant fixture with a horizontal buccal gap greater than 2 mm. A person with adequate oral hygiene with a plaque index less than or equal to 20 percent 18 years no limit Both People who smoke or are addicted to drugs or alcohol People who are pregnant or have systemic diseases such as diabetes, or if they are taking antibiotics or drugs that weaken the immune system such as corticosteroids. Probing depth greater than three millimeters buccally or lingually The need for bone grafting at the same time as implant placement Presence of local or systemic conditions that are contraindications to implant placement Other Other Other Other Intervention group: In the Xenograft group, cera bone with particle sizes of 150-1000 microns was hydrated in normal saline for 10 minutes and packed in the buccal gap area up to the bone crest area. Intervention group: In the L-PRF group, after blood collection from the brachial artery, it is placed in 2 red 9 ml test tubes in a centrifuge at 2700 rpm for 12 minutes. After this time, the obtained L-PRF is separated from the red blood cells and packed by the special area in the PRF kit to produce L-PRF plug. Intervention grouIn the buccal gap filling e-PRF group, after blood collection from the brachial artery in a 9 ml white test tube, it is centrifuged at 700 rpm for 8 minutes. After that, to prepare e-PRF, first 2 ml of the liquid was obtained. In the test tube, which is PPP (platelet poor plasma), it is aspirated using a 3 ml locking syringe And this syringe is placed in a heater for 10 minutes at 75°C to coagulate the proteins. During this time, the test tubes are placed in the refrigerator to prevent coagulation. After ten minutes, the syringes are removed from the heater and placed in the refrigerator to reach room temperature, and the centrifuge tubes are removed from the refrigerator and their plastic lids are opened and the L-PRF layer and buffy coat are aspirated using a locking syringe. The syringe containing the PPP is coagulated and PRF is connected using the syringe connector, and the contents of the syringe are mixed and injected into the buccal gap and packed up to the gingival margin using a condenser. Control group: In the control group, no material is placed in the buccal gap. Buccal bone thickness (post-surgery): Linear measurement of the distance between the external surface of the bone and the implant shoulder at distances of 0, 2, 4, and 6 mm from the implant shoulder perpendicular to the long axis of the implant. Timepoint: At the beginning of the study and 3 months after surgery. Method of measurement: Measurements of the width of the socket in the coronal and apical sections, perpendicular to the longitudinal axis of the socket, are made linearly on the 3D image DIACOM file, by a person who is unaware of the grouping. Implant coverage by bone: Percentage of implant height covered by bone in the buccal areas. Timepoint: 3 months after surgery. Method of measurement: Bone thickness and height (percentage of implant covered by bone both buccally and lingually) are performed linearly on the 3D image dycom file by a person who is unaware of the grouping. Soft tissue thickness. Timepoint: Beginning of the intervention and three months later. Method of measurement: Endo file and gauge. Distance of the gingival margin from the edge of the healing abutment. Timepoint: Beginning of the intervention and three months later. Method of measurement: Periodontal probe, parallel to the longitudinal axis of healing. Keratinized gingival width. Timepoint: Beginning of the intervention and three months later. Method of measurement: Periodontal probe. Soft tissue contour. Timepoint: Before the intervention and three months later. Method of measurement: Preparation of a digital file of the buccal soft tissue contour in format standard tessellation language and superimposition format to examine changes in the soft tissue contour. University of Medical Sciences Approved 2025-11-10 Ethics Committee of Kerman University of Medical Sciences Research Ethics Committee, Kerman University of Medical Sciences, Beginning of Haft Bagh Alavi Axis, University of Medical Sciences Campus Kerman Kerman Iran (Islamic Republic of)