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Clinical Trials/NCT07424573
NCT07424573
Active, not recruiting
Not Applicable

Autogenous Bone Block Versus Extended Platelet Rich Fibrin Block Used for Horizontal Augmentation of Atrophic Esthetic Zone of Maxillary Ridge Associated With Simultaneous Implant Placement

Naira elnagar1 site in 1 country20 target enrollmentStarted: May 9, 2024Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Naira elnagar
Enrollment
20
Locations
1
Primary Endpoint
bone width

Overview

Brief Summary

The aim of the study is directed to assess the clinical and radiographic outcomes of autogenous bone block versus extended PRF block used for horizontal augmentation of atrophied esthetic area of maxillary ridge associated with simultaneous implant placement.

Detailed Description

Twenty implants inserted in 16 patients will be randomly and uniformly distributed into two equal groups:

Group I: Ten dental implants will be inserted simultaneously in eight patients with horizontal ridge augmentation done by symphyseal onlay autogenous block technique.

Group II: Ten dental implants will be inserted simultaneously in nine patients with horizontal ridge augmentation done by onlay extended platelet rich fibrin technique using a mixture of allografts and xenografts.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

quadruple ( participant, care provider, investigator, outcomes assessor)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Maxillary narrow ridge in the esthetic anterior zone (about 4-5 mm in width).
  • Bone height allows the insertion of at least 8 mm of implant length without the need for vertical augmentation.
  • Patient aged 18-45 years old.
  • The presence of enough amount of keratinized gingiva as well as enough space for prosthesis rehabilitation.
  • Favorable occlusion without presence of parafunctional habits.
  • Cooperative patient with high motivation and acceptable oral hygiene.
  • Patients are medically free from systemic diseases or drugs that absolutely contraindicate implant surgery.
  • Patients able to comply with the required recall visits.

Exclusion Criteria

  • Local and / or systemic conditions that may affect passively the clinical procedure or results.
  • Heavy smokers(\>20 cigarettes/d).(1)
  • Alcohol or drug abuse.
  • Patients with parafunctional habits (bruxism and clenching).
  • Pregnancy.
  • Uncooperative patients.

Arms & Interventions

Group I ( autogenous bone block)

Experimental

Ten dental implants will be inserted simultaneously with horizontal ridge augmentation done by onlay autogenous block technique.

Intervention: group I: autogenous bone block (Procedure)

Group II ( e-prf block)

Experimental

Ten implants were inserted in 9 patients with horizontal augmentation with eprf block.

Intervention: extented platelet rich fibrin (Procedure)

Outcomes

Primary Outcomes

bone width

Time Frame: immediately after augmentation and implant placement (T0), and after 3 months (at time of implant loading) (T3) and after six months from implant loading (T6) (totally, 9 months follow up)

The horizontal bone gain resulted from the ridge augmentation was measured at 2,4,6 mm apical to the alveolar crest level, then the mean was calculated. This calculation was done at T0 (BG0), T3 (BG3) and T6 (BG6).

Secondary Outcomes

  • bone area(immediately after augmentation and implant placement (T0), and after 3 months (at time of implant loading) (T3) and after six months from implant loading (T6) (totally, 9 months follow up))
  • marginal bone loss(immediately after augmentation and implant placement (T0), and after 3 months (at time of implant loading) (T3) and after six months from implant loading (T6) (totally, 9 months follow up))
  • Relative Alveolar Bone Density(immediately after augmentation and implant placement (T0), and after 3 months (at time of implant loading) (T3) and after six months from implant loading (T6) (totally, 9 months follow up))
  • Bone volume(immediately after augmentation and implant placement (T0), and after 3 months (at time of implant loading) (T3) and after six months from implant loading (T6) (totally, 9 months follow up))
  • Postoperative Pain(on the 1st, 3rd, and 7th days after augmentation surgery)
  • Landry Healing Index for Wound Healing Evaluation(immediately at 14th day during suture removal visit, one month and 3 months after surgery.)
  • Modified sulcus bleeding Index (mSBI)(It was recorded immediately after implant loading and after 6 months of loading.)
  • Peri-implant pocket depth (PPD)(immediately after implant loading and after 6 months of loading)
  • Measurement of implant stability(immediately after the placement (T0) and after three months at time of implant loading (T3), then after six months from implant loading (T6).)

Investigators

Sponsor
Naira elnagar
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Naira elnagar

Msc, Teaching assistant, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University.

Mansoura University

Study Sites (1)

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