Buccal Plate Augmentation Using Sticky Bone With Simultaneous Immediate Implant Placement

NCT06642753 | Recruiting DMC

• 1 other identifier: PER.6-3-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Immediate Implant

Keywords

buccal plate preservation; sticky bone; PRF

Outcome Measures

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.

  3 and 6 months postoperative

Secondary Outcomes (4)

• crestal bone level

  baseline and 6 months post operative

• Thickness of labial plate of bone

  baseline and 6 months postoperatively

• Soft tissue profile /contour

  baseline, 3 and 6 months postoperatively.

• patient satisfaction

  immediately after implant placement , 3 and 6 months postoperative

Study Arms (2)

immediate implant with buccal plate augmentation using sticky bone

EXPERIMENTAL

atraumatic extraction. * The socket will be well irrigated with saline and debrided with a bone curette. * placement of the implant. * Venous blood will be withdrawn and transferred into sterile tubes which will be devoid of anticoagulants.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. * sticky bone will be ready to be grafted. * Sticky bone will be inserted into the pouch by a mean of a small periosteal elevator. Additional graft material will be added and compressed until adequate filling of the pouch is achieved without overstretching the soft tissues. * the healing abutment will be screwed into the implant body .

Biological: immediate implant with buccal plate augmentation using sticky bone

immediate implant with sticky bone as a filling material in the jumping gap

ACTIVE COMPARATOR

* atraumatic extraction. * The socket will be well irrigated with saline and debrided with a bone curette. * placement of the implant. * 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. * sticky bone will be ready to be grafted. * The sticky bone graft will be condensed and adapted into the jumping gap as well as over the implants. Further, it will be covered with PRF membrane. * the healing abutment will be screwed into the implant body

Biological: immediate implant with sticky bone as a filling material in the jumping gap

Interventions

immediate implant with buccal plate augmentation using sticky bone BIOLOGICAL

* 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 buccal plate augmentation using sticky bone

immediate implant with sticky bone as a filling material in the jumping gap BIOLOGICAL

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 jumping gap.

immediate implant with sticky bone as a filling material in the jumping gap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.
• Patients showing motivation to comply with post-operative care instructions and follow- up appointments.

You may not qualify if:

• 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.
• Smokers

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, 12613, Egypt

RECRUITING

Study Officials

• Enji ahmed, professor

  Cairo University

  STUDY DIRECTOR

• shaimaa Nasr, Ass. Prof

  Cairo University

  STUDY CHAIR

• Yara Kh Ghaith, Bachelor

  Cairo University

  PRINCIPAL INVESTIGATOR

• samah bahaa, Lecturer

  Cairo University

  STUDY CHAIR

Central Study Contacts

Yara KH Ghaith

CONTACT

01025718437; yara.khalefa@dentistry.cu.edu.eg

Enji ahmed, Professor

CONTACT

Enji.Ahmed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator yara khaled Master Degree student, Periodontology department, Faculty of Dentistry, Cairo University

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: October 15, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-09

Locations

EG (1)