NCT07159529

Brief Summary

this study aimed to evaluate both clinically and radiographically the effect of flapless versus flap techniques on initial crestal bone loss and osseointegration of dental implants in lower posterior area. the study is to designed to observe the clinical outcomes such as primary stability and pain within initial hours and days and secondary stability over a 6 month period .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 23, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

August 29, 2025

Last Update Submit

August 29, 2025

Conditions

Keywords

flap and flapless dental implant insertion techniques

Outcome Measures

Primary Outcomes (1)

  • crestal bone loss and osseointegration

    initial crestal bone loss around the dental implants measured radiographically and secondary stability checked after six months to check osseointegration of the dental implants by resonance frequency analysis device.

    6 months postoperatively

Study Arms (2)

flapless group

EXPERIMENTAL

10 patients received dental implants just by taking a punch of tissue

Procedure: flapless techniqueProcedure: tissue punching

flap group

EXPERIMENTAL

conventional flap elevation to place dental imp;lant

Procedure: flap technique

Interventions

taking a punch of tissue to place dental implant through surgical guide

flapless group

conventional flap elevation and drilling to place dental implant

flap group

just a punch of tissue taken to place dental implant

flapless group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients that fulfill one or more of the following criteria were included:
  • Residual bone height of alveolar ridge more than 8 mm.
  • Residual bone width of alveolar ridge more than 4 mm.
  • Healthy and sufficient covering soft tissue (keratinized mucosa).
  • Distance between inferior border of mandible and the crest of alveolar ridge more than 2cm.
  • Motivated, cooperative patients with good oral hygiene.

You may not qualify if:

  • Patients with relevant systemic disorder that may compromise bone healing (e.g.: Uncontrolled diabetic).
  • Extraction socket less than 4 months of healing time.
  • Patient with Autoimmune disease, or neurologic disorder.
  • Heavy smokers (more than 15 cigarettes/day).93
  • Bad oral hygiene.
  • Patients with history of radiotherapy or chemotherapy.
  • Patients who are fully edentulous.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location

Study Officials

  • Marwa Taha Ibrahim, Assistant Professor

    faculty of Dentistry, Tanta University, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: participants of this study trial were divided into two groups,a group of them received dental implants with flapless technique and the other group of participants received dental implants with conventional flap elevation technique.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 8, 2025

Study Start

May 23, 2024

Primary Completion

January 31, 2025

Study Completion

February 27, 2025

Last Updated

September 8, 2025

Record last verified: 2025-08

Locations