Peri-Implant Soft and Hard Tissue Stability Following Socket Preservation

NCT05005377 | Completed

• 1 other identifier: 1396.261
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The viability of Platelet Rich Fibrin (PRF) on enhancement of osseous and associated tissue healing has been substantiated well in literature. This study aimed to assess peri-implant soft and hard tissue changes after prosthetic loading of implants following socket preservation with platelet-rich fibrin (PRF) and freeze-dried bone allograft (FDBA) in a 12-month period. This Study evaluated 48 patients who were randomly divided into two groups for anterior ridge preservation with PRF and FDBA. At 12 months after implant placement and prosthetic delivery, bone loss was evaluated radiographically while soft tissue changes were evaluated by measuring gingival recession, papilla index, and bleeding on probing (BOP). The differences between the PRF and FDBA groups were analyzed using Fisher's exact test and student's t-test (P\<0.05).

Conditions

Alveolar Ridge Augmentation; Bone Transplantation

Outcome Measures

Primary Outcomes (12)

• mean vertical ridge resorption

  Mean bone loss around implants measured using Scanora software (SCANORA lite, Soredex, Helsinki, Finland), the distance from the crestal bone-fixture interface to the abutment-crown interface (crown margin) was measured at the mesial and distal surfaces of the implant immediately after implant placement. These measurements were repeated 3 times at the mesial and 3 times at the distal surfaces for each patient and the mean values reported to minimize the errors.

  0 month

• mean vertical ridge resorption

  Mean bone loss around implants measured using Scanora software (SCANORA lite, Soredex, Helsinki, Finland), the distance from the crestal bone-fixture interface to the abutment-crown interface (crown margin) was measured at the mesial and distal surfaces of the implant 6 months after implant placement. These measurements were repeated 3 times at the mesial and 3 times at the distal surfaces for each patient and the mean values reported to minimize the errors.

  6 month

• mean vertical ridge resorption

  Mean bone loss around implants measured using Scanora software (SCANORA lite, Soredex, Helsinki, Finland), the distance from the crestal bone-fixture interface to the abutment-crown interface (crown margin) was measured at the mesial and distal surfaces of the implant 12 months after implant placement. These measurements were repeated 3 times at the mesial and 3 times at the distal surfaces for each patient and the mean values reported to minimize the errors.

  12 month

• Mean Gingival Recession

  gingival recession was defined as the changes in the distance from the gingival margin to the crown margin )

  0 month

• Mean Gingival Recession

  gingival recession was defined as the changes in the distance from the gingival margin to the crown margin compared with time 0)

  6 month

• Mean Gingival Recession

  gingival recession was defined as the changes in the distance from the gingival margin to the crown margin compared with time 0)

  12 month

• Changes in Papilla Index

  it was measured via the distance from the tip of the papilla to the crown margin in the mesial and distal surfaces of the restoration

  0 month

• Changes in Papilla Index

  it was measured via the distance from the tip of the papilla to the crown margin in the mesial and distal surfaces of the restoration

  6 month

• Changes in Papilla Index

  it was measured via the distance from the tip of the papilla to the crown margin in the mesial and distal surfaces of the restoration

  12 month

• Frequency of bleeding on probing

  was measured at the mesiobuccal and distobuccal points of the restoration

  0 month

• Frequency of bleeding on probing

  was measured at the mesiobuccal and distobuccal points of the restoration

  6 month

• Frequency of bleeding on probing

  was measured at the mesiobuccal and distobuccal points of the restoration

  12 month

Study Arms (2)

Socket Preservation with Platelet-Rich Fibrin

EXPERIMENTAL

10cc of blood was drawn from each patient and centrifuged at 2700 revolutions per minute (rpm) for 12 minutes to obtain PRF. The extraction socket was filled with PRF and covered using a membrane made of PRF.

Procedure: Socket Preservation with Platelet-Rich Fibrin

Socket Preservation with Freeze-Dried Bone Allograft

EXPERIMENTAL

the extraction socket was filled with FDBA (CenoBone®; Tissue Regeneration Corp., Kish Island, Iran) without flap elevation. The socket was covered using a free palatal mucosal graft obtained by the pouch technique.

Procedure: Socket Preservation with Freeze-Dried Bone Allograft

Interventions

Socket Preservation with Platelet-Rich Fibrin PROCEDURE

10cc of blood was drawn from each patient and centrifuged at 2700 revolutions per minute (rpm) for 12 minutes to obtain PRF. The extraction socket was filled with PRF and covered using a membrane made of PRF.

Socket Preservation with Platelet-Rich Fibrin

Socket Preservation with Freeze-Dried Bone Allograft PROCEDURE

The extraction socket was filled with FDBA (CenoBone®; Tissue Regeneration Corp., Kish Island, Iran) without flap elevation. The socket was covered using a free palatal mucosal graft obtained by the pouch technique.

Socket Preservation with Freeze-Dried Bone Allograft

Eligibility Criteria

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

You may qualify if:

• Patients over 18 years of age, who were referred for extraction of the hopeless teeth. The reasons for tooth extraction included root fracture, failed root canal therapy, and extensive non-restorable caries.

You may not qualify if:

• a history of systemic disease and head/neck radiotherapy, use of drugs affecting bone metabolism, smoking more than 10 cigarettes per day, the presence of significant periapical or periodontal lesions around the respective teeth, and the presence of dehiscence or fenestration larger than 3mm in the buccal bone plate.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Related Publications (1)

• Azangookhiavi H, Habibzadeh S, Zahmatkesh H, Mellati E, Mosaddad SA, Dadpour Y. The effect of platelet-rich fibrin (PRF) versus freeze-dried bone allograft (FDBA) used in alveolar ridge preservation on the peri-implant soft and hard tissues: a randomized clinical trial. BMC Oral Health. 2024 Jun 14;24(1):693. doi: 10.1186/s12903-024-04478-1.

  PMID: 38877446 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator who analyzed the data was blinded from the procedure ( The participants were assigned to A and B groups and it was not clear for the investigator which data belonged to which procedure).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 48 patients were randomly divided into two groups for anterior ridge preservation with PRF and FDBA. At 12 months after implant placement and prosthetic delivery, bone loss was evaluated radiographically while soft tissue changes were evaluated by measuring gingival recession, papilla index, and bleeding on probing (BOP).

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 13, 2021
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2020
• Last Updated: August 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share