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NCT Number: NCT07424573

Autogenous Bone Block Versus Extended Platelet Rich Fibrin Block for Horizontal Augmentation of Maxillary Ridge With Simultaneous Implant Placement

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

group I: autogenous bone block

Procedure

Full thichness flap is done and the implant is inserted in place. After that, an autogenous block is harvested from the symphyseal area and fixed in the area of the defect

extented platelet rich fibrin

Procedure

Full thickness flap is made and the implant is inserted in place. After that the platelet rich fibrin is collected from the patient blood and heated to produce e-platelet rich fibrin, mixed with a mixture of allograft and xenograft to make e-platelet rich fibrin block placed in the defect area

Primary outcomes

  1. 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

  1. bone area

    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 area resulted from the ridge augmentation was measured at T0 (BG0), T3 (BG3) and T6 (BG6).

  2. marginal bone loss

    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)

    On the cross-sectional view, a line was drawn buccally and lingually just parallel to the long axis of the implant, starting at the most cervical bone implant contact to the apex of the implant. Bone height in millimeters was recorded at immediate postsurgical phase after implant insertion. Vertical bone loss was calculated by subtracting recorded marginal bone level value buccally and lingullay after 3 months (at time of implant loading (T3) and after 6 months of implant loading (T6) from immediate postoperative value (T0).

  3. Relative Alveolar Bone Density

    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)

    All density records were collected from the cross-sectional view of CBCT using the Hounsfield unit (HU) according to Misch's classification. ROI tool was used representing the average estimated bone density at 3 mid-buccal levels of the placed implant at T0 (immediately after surgery) and after 3 months (at time of implant loading (T3) and after 6 months of implant loading (T6), in comparison to the primary measures.

  4. Bone volume

    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 volume of the gained bone resulted from the ridge augmentation was measured at T0 (BG0), T3 (BG3) and T6 (BG6).

  5. Postoperative Pain

    Time frame: on the 1st, 3rd, and 7th days after augmentation surgery

    • By using a 10-point Visual Analogue Scale (VAS) for assessment of pain by the patient on the 1st, 3rd, and 7th days after augmentation surgery.

    (0-1=None, 2-4=Mild, 5-7=Moderate, 8-10=Severe)

  6. Landry Healing Index for Wound Healing Evaluation

    Time frame: immediately at 14th day during suture removal visit, one month and 3 months after surgery.

    • The area of operation was examined by using healing index by Landry et al., this index scores clinical signs and symptoms of infection as redness, hotness, pus discharge, bleeding and pain. In addition to that, any manifestations of wound healing disturbance including wound dehiscence and exposure of underlying bone graft were recorded carefully.
  7. Modified sulcus bleeding Index (mSBI)

    Time frame: It was recorded immediately after implant loading and after 6 months of loading.

    Clinical signs and symptoms of inflammation of peri-implant mucosa were graded using criteria of mSBI. It was recorded immediately after implant loading and after 6 months of loading at four aspects around the implants; buccal, lingual, mesial, and distal. The four readings were averaged and approximated to nearest 0.5.

  8. Peri-implant pocket depth (PPD)

    Time frame: immediately after implant loading and after 6 months of loading

    Depth of the peri-implant sulcus was recorded immediately after implant loading and after 6 months of loading. The distance between the gingival margin and the base of the pocket was recorded using a graduated periodontal probe with light force to avoid undue tissue damage and over-extension into the healthy tissue. The probe was inserted buccally, mesially, lingually and distally around each implant in a line parallel to the implant vertical axis until the blunt end of the probe reached the base of the pocket. The four readings were averaged and approximated to nearest 0.5mm.

  9. Measurement of implant stability

    Time frame: immediately after the placement (T0) and after three months at time of implant loading (T3), then after six months from implant loading (T6).

    The primary Implant Stability Quotient (ISQ) was measured by using a resonance frequency analyzer (Osstell device) immediately after the placement (T0) and after three months at time of implant loading (T3), then after six months from implant loading (T6). RFA technology depends on fork tuning principle. A Smart Peg was attached to the implant and torqued to 10 Ncm and then the peg was made to vibrate just like a tuning fork by the Osstell device. The purpose here was to find the resonance frequency with the strongest vibration.

Sponsors and collaborators

Lead sponsor

Naira elnagar

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.