NCT06845449

Brief Summary

After administering local anesthesia,. A full-thickness mucoperiosteal flap will be incised and be reflected to expose the alveolar bone. The dimensions of the defect will be measured using a periodontal probe to determine the appropriate size of the block graft or the quantity of particle bone graft required. In the non screw group, the blocks will be adapted to fit the recipient sites and secured to the alveolar bone using titanium bone fixation screws. Following the placement of the blocks, bovine particles will be applied over the graft and into any remaining gaps between the block and the recipient site, a resorbable collagen membrane (CM) will be shaped and placed over the graft and fixed using subperiosteal sutures. In Tenting screw cases, the screws will be placed in suitable positions and depths, blocks will be crushed into particulates which will then be mixed with equal amount of bovine particles. the mixture will be applied to the recipient site all around the tenting screws a resorbable collagen membrane (CM) will be shaped and placed over the graft and fixed using subperiosteal sutures. The flaps will then be sutured

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

February 20, 2025

Last Update Submit

March 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Horizontal bone width gain

    6months

Study Arms (2)

tenting screw group

EXPERIMENTAL
Procedure: tenting screw combined with particulate autogenous

non screw group

ACTIVE COMPARATOR
Procedure: autogenous ring block grafts combined with xenogenic bone

Interventions

In Tenting screw cases, the screws will be placed in suitable positions and depths, blocks will be crushed into particulates which will then be mixed with equal amount of bovine particles. the mixture will be applied to the recipient site all around the tenting screws a resorbable collagen membrane (CM) will be shaped and placed over the graft and fixed using subperiosteal sutures.

tenting screw group

In the non screw group, the blocks will be adapted to fit the recipient sites and secured to the alveolar bone using titanium bone fixation screws. Following the placement of the blocks, bovine particles will be applied over the graft and into any remaining gaps between the block and the recipient site, a resorbable collagen membrane (CM) will be shaped and placed over the graft and fixed using subperiosteal sutures

non screw group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has anterior maxillary horizontal defect less than 4mm in the alveolar ridge and (classified as class III or IV atrophy according to Cawood and Howell classification). (Cawood \& Howell, 1988require horizontal bone augmentation in anterior maxilla before dental implant placement and in need of an implant-supported restoration in at least one site,
  • Adult individuals aged 18 years or older
  • Satisfactory oral hygiene,
  • No previous history of bone augmentation procedures at the site to be treated in the study,
  • The ability to comprehend and provide informed consent.

You may not qualify if:

  • Uncontrolled systemic disorders,
  • Prior irradiation in the head and neck region,
  • Immunosuppression or compromised immune system,
  • Oral disorders such as lichen planus, ongoing or recent treatment with intravenous amino- bisphosphonates, untreated periodontitis,
  • Poor oral hygiene and motivation,
  • Parafunctional habits, pregnancy or lactation,
  • Substance abuse involving drugs or alcohol, psychiatric disorders, a history (within the last 3 months) of regular use of smokeless chewing tobacco, smoking a pipe, cigar, or more than 10 cigarettes per day, acute or chronic infection or inflammation in the area, or
  • Extraction with less than 3 months of healing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nahda University

Beni-seuf, 2711860, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 25, 2025

Study Start

March 10, 2025

Primary Completion

January 1, 2026

Study Completion

February 27, 2026

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations