Injectable Platelets Rich Fibrin Versus Hyaluronic Acid for Alveolar Ridge Preservation

NCT05781529 | Completed DMC

• 1 other identifier: 21832
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

Thirty-six patients (19 females and 17 males) that required implant placement in esthetic zone participated in this study and were blindly allocated 12 patients per group, all patients had ARP either with I-PRF with xenograft, HA with xenograft or xenograft alone, the sockets were sealed with free gingival graft harvested from the palate.

Conditions

Alveolar Ridge Enlargement

Outcome Measures

Primary Outcomes (1)

• Radiographic bone width

  Cone beam CT (CBCT) were obtained preoperatively and 4 months postoperatively. The radiographs were analyzed using One- Viewer viewing software (iCATVision). The buccolingual width was measured into different levels. At the bone crest (A), 3mm from the bone crest (B) and 6 mm from the bone crest (C). For standardization in the sagittal slice, the axial plane was adjusted to pass through the cemento enamel junction (CEJ) of the adjacent teeth. On the axial slice, the mesiodistal dimension from the distal surface to mesial surface of the adjeceent teeth was measured. The coronal plane was adjusted to be pass through the middle of the distance in order to be perpendicular to both buccal and lingual cortices. Measurement were all performed on the coronal slices. In addition, fusion was done by superimposing preoperative and 4 months CBCT in all groups.

  4 months postoperative

Secondary Outcomes (1)

• histological and histomorphometric assessment

  4 months postoperative

Study Arms (3)

Injectable platelets rich fibrin

EXPERIMENTAL

Injectable platelets rich fibrin was prepared where 10 ml of patient venous blood was centrifuged without anti-coagulants (plain plastic glass-coated) at 700 rpm speed for only 3 minutes, xenograft was mixed with I-PRF to make sticky bone, sticky bone was placed into extraction socket till the socket was fully filled up to the gingival margin

Procedure: Alveolar ridge augmentation with injectable platelets rich fibrin

Hyaluronic acid

EXPERIMENTAL

Hyaluronic acid (HA) syringe containing 1 mL of cross-linked hyaluronic at a concentration of 20 mg/ml in a saline phosphate buffer solution at sterilized content was used. HA was mixed with particulate xenograft 1:10 ratio to form a putty consistency for condensation and was placed into extraction socket till the socket was fully filled up to the gingival margin

Procedure: Alveolar ridge augmentation with hyaluronic acid

Xenograft

ACTIVE COMPARATOR

Xenograft was mixed with saline, placed in extraction socket till the socket is fully filled up to the gingival margin

Procedure: Alveolar ridge augmentation with xenograft

Interventions

Alveolar ridge augmentation with injectable platelets rich fibrin PROCEDURE

Injectable platelets rich fibrin is added to xenograft for alveolar ridge augmentation in order to preserve bone and decrease bone resorption

Also known as: Socket augmentation with injectable platelets rich fibrin

Injectable platelets rich fibrin

Alveolar ridge augmentation with hyaluronic acid PROCEDURE

Hyaluronic is added to xenograft for alveolar ridge augmentation in order to preserve bone and decrease bone resorption

Also known as: Socket augmentation with hyaluronic acid

Hyaluronic acid

Alveolar ridge augmentation with xenograft PROCEDURE

Xenograft is added alone as a active compatator

Also known as: Socket augmentation with xenograft

Xenograft

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• non-restorable tooth located in anterior maxillary arch (upper right second premolar to upper left second premolar)
• socket type I according to Elian et al., 2007 classification
• tooth to be extracted was free from acute periapical infection or sinus tracts
• thick gingival biotype
• Systemically free according to modified Cornell medical index

You may not qualify if:

• smokers patients
• bruxism habits
• patients with poor oral hygiene or not willing to perform oral hygiene measures

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Doaa Adel Salah Khattab

Cairo, Abbassia, 11566, Egypt

Location

Doaa Khattab

Cairo, Abbassia, 11566, Egypt

Location

Related Publications (1)

• Abaza G, Abdel Gaber HK, Afifi NS, Adel-Khattab D. Injectable platelet rich fibrin versus hyaluronic acid with bovine derived xenograft for alveolar ridge preservation. A randomized controlled clinical trial with histomorphometric analysis. Clin Implant Dent Relat Res. 2024 Feb;26(1):88-102. doi: 10.1111/cid.13289. Epub 2023 Oct 31.

  PMID: 37905704 DERIVED

MeSH Terms

Interventions

Alveolar Ridge Augmentation; Hyaluronic Acid; Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Glycosaminoglycans; Polysaccharides; Carbohydrates; Transplantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 23, 2023
• Study Start: March 6, 2019
• Primary Completion: July 16, 2021
• Study Completion: August 31, 2021
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (2)