NCT07534787

Brief Summary

This study aims to evaluate the tissue biotype and bone density around dental implants in patients with narrow alveolar ridge. Ridge splitting with simultaneous implant placement covered with concentrated growth factor (CGF) membranes will be performed. Clinical and radiographic evaluation will be done using periodontal probe and CBCT. Pain will also be assessed using visual analogue scale (VAS) during follow-up period.

Trial Health

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Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

April 16, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

April 10, 2026

Last Update Submit

April 10, 2026

Conditions

Keywords

Ridge splittingDental implantsConcentrated growth factor (CGF)Bone densityTissue biotype

Outcome Measures

Primary Outcomes (1)

  • Pain (VAS score)

    Pain will be assessed using Visual Analogue Scale (VAS) ranging from 0 to 10.

    1st day and 3rd day postoperative

Secondary Outcomes (1)

  • Tissue biotype thickness

    Immediately postoperative and after 4 months

Other Outcomes (1)

  • Bone density

    Immediately postoperative and after 4 months

Study Arms (1)

Ridge Splitting with Simultaneous Implant Placement and CGF

EXPERIMENTAL

Patients with narrow alveolar ridge will undergo ridge splitting with simultaneous implant placement. Concentrated growth factor (CGF) membranes will be prepared from the patient's blood and placed over the grafted area. Autologous bone chips will be used for augmentation. Clinical and radiographic evaluation will be performed to assess tissue biotype, bone density, and pain during follow-up period.

Procedure: Ridge splittingProcedure: Dental implant placementBiological: Concentrated Growth Factor (CGF)

Interventions

Patients with narrow alveolar ridge will undergo ridge splitting procedure using chisel to allow implant placement.

Ridge Splitting with Simultaneous Implant Placement and CGF

Intervention Description: Dental implants will be inserted simultaneously after ridge splitting in the prepared alveolar ridge.

Ridge Splitting with Simultaneous Implant Placement and CGF

CGF membranes will be prepared from patient venous blood and placed over the grafted area to enhance healing and tissue regeneration.

Ridge Splitting with Simultaneous Implant Placement and CGF

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with narrow alveolar ridge indicated for implant placement Age between 20 and 50 years Good general health Patients with adequate oral hygiene

You may not qualify if:

  • Patients with systemic diseases affecting bone healing Smokers Pregnant or lactating females Patients with poor oral hygiene Patients with history of radiation therapy in the head and neck region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo university

Cairo, Egypt

Location

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Hesham Said Said, Professor

    Cairo University

    STUDY CHAIR
  • Abdelmoez Mohamed El-Sharkawy, Associate professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Tasneem Farrag Ayoub, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's degree student, Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 16, 2026

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

April 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations