Buccal Plate Augmentation Using Sticky Bone With Simultaneous Immediate Implant Placement
ConditionImmediate Implant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University
About this trial
the aim of this study is to clinically assess pink esthetic score following Buccal Plate Augmentation using Sticky Bone versus usage of Sticky Bone as a jumping gap filling material with simultaneous immediate implant placement in the maxillary esthetic zone
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients aged 18 years or older.
Presence of a non-restorable maxillary tooth in the esthetic zone including maxillary anteriors and premolars indicated for extraction.
An intact buccal plate of bone after extraction.
Full-mouth plaque and bleeding score not exceeding 20%.
Disqualifiers
Periapical infection involving the tooth to be extracted.
Periodontal disease
Systemic health conditions that contraindicate or affect healing of implant surgery (Diabetes Mellitus, Leukemia)
Pregnant and nursing females.
Trial design
Design model
Parallel
Treatments tested in this trial
immediate implant with buccal plate augmentation using sticky bone
Biological/Vaccine* Venous blood will be withdrawn and transferred into sterile tubes which will be devoid of anticoagulants. I- PRF preparation will be done using the protocol developed by Mourãoet al. * Plastic PET tubes to create Liquid-PRF, while glass tubes will be used to obtain Solid-PRF. * Blood will be centrifuged at a speed of 3000 rpm for 10 minutes to obtain autologous PRF plug. * Blood will be centrifuged at a speed of 700 rpm for 3 minutes. An orange- colored fluid will be formed as the upper layer in the test tubes i.e., I- PRF. Approximately 1 ml of I-PRF will be collected in a syringe. * Solid-PRF + Liquid-PRF mixed DBBM: Solid-PRF membranes will be mixed thoroughly with 0.25 g of DBBM particles. Then 1 mL Liquid PRF from the buffy coat layers will be added drop by drop to the DBBM. * Following polymerization by 15-20 minutes, sticky bone will be ready to be grafted in the pouch .
immediate implant with sticky bone as a filling material in the jumping gap
Biological/VaccineVenous blood will be withdrawn and transferred into sterile tubes which will be devoid of anticoagulants. I- PRF preparation will be done using the protocol developed by Mourãoet al. * Plastic PET tubes to create Liquid-PRF, while glass tubes will be used to obtain Solid-PRF. * Blood will be centrifuged at a speed of 3000 rpm for 10 minutes to obtain autologous PRF plug. * Blood will be centrifuged at a speed of 700 rpm for 3 minutes. An orange- colored fluid will be formed as the upper layer in the test tubes i.e., I- PRF. Approximately 1 ml of I-PRF will be collected in a syringe. * Solid-PRF + Liquid-PRF mixed DBBM: Solid-PRF membranes will be mixed thoroughly with 0.25 g of DBBM particles. Then 1 mL Liquid PRF from the buffy coat layers will be added drop by drop to the DBBM. * Following polymerization by 15-20 minutes, sticky bone will be ready to be grafted in the jumping gap.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: immediate implant with buccal plate augmentation using sticky boneExperimental treatment 1 intervention
Group B: immediate implant with sticky bone as a filling material in the jumping gapActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
pink esthetic score
This pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency .With the exception of papilla formation, the evaluation is performed visually by comparing reference teeth (i.e., with the contralateral tooth in the incisor zone and adjacent tooth in the premolar zone). For the mesial and distal papilla, the categories are complete, incomplete, and absent. For each criterion it is possible to award a score between two points (for a very good outcome) and no points (for a poor outcome). The maximum score that can be achieved is 14 points indicating an outcome that reflects complete conformity between the soft tissue of the tooth being assessed and that of the reference tooth.
Time frame
3 and 6 months postoperativeSecondary outcomes
1
crestal bone level
using Cone beam computed tomography (CBCT) machine with superimposition technique.
Time frame
baseline and 6 months post operative2
Thickness of labial plate of bone
Using CBCT machine . Using the axial view, one reference line will be drawn from the apex of the implant to its platform (long axis); another line, perpendicular to the one at the long axis, will be drawn at the apex of the implant. Parallel to this, two lines will be drawn, one at 1 mm from the implant collar (R1) and another 5 mm apical to it (R2) measuring the thickness of the bone (at the buccal plate) to the nearest 0.1 mm.
Time frame
baseline and 6 months postoperatively3
Soft tissue profile /contour
Scanning of diagnostic casts by optical scanner.
Time frame
baseline, 3 and 6 months postoperatively.4
patient satisfaction
VAS (Visual analogue scales ) based questionnaire. for pain: The most common VAS consists of a 10-cm horizontal or vertical line with the two endpoints labeled "no pain" and "worst pain ever" (or similar verbal descriptors). The patient is required to place a mark on the 10-cm line at a point that corresponds to the level of pain intensity they presently feel. The distance in centimeters from the low end of the VAS to the patient's mark is used as a numerical index of the severity of pain. for swelling: 1. no swelling. 2. mild intraoral swelling 3. moderate intraoral swelling 4. severe extraoral swelling
Time frame
immediately after implant placement , 3 and 6 months postoperativeSponsors and contacts
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Source ClinicalTrials.gov