Flapless Versus Flap Technique for Evaluation of Crestal Bone Loss and Osseointegration of Dental Implants

NCT ID: NCT07159529

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-23

Study Completion Date

2025-02-27

Brief Summary

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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 .

Detailed Description

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this clinical trial was designed to observe the clinical outcomes of techniques of implant installation including flapless and flap techniques about their effect on; osseointegration that measured by checking dental implants stability with resonance frequency analysis device after 6 months of their installation, initial crestal bone loss around the dental implants after 6 months of their installation that that evaluated radiographically and also recording pain perception by the patients within the initial hours and days after implant insertion by both techniques.The patients collected and operated from department of Oral and Maxillofacial surgery, Faculty of Dentistry, Tanta University, Egypt.

Approval of this research was obtained from Faculty of Dentistry, Tanta University Research Ethics Committee (REC). The purpose of the present study was explained to the patients and informed consents were obtained according to the guidelines on human research published by the REC at Faculty of Dentistry, Tanta University.

Conditions

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Posterior Mandible Missing Tooth and /or Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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flapless group

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

Group Type EXPERIMENTAL

flapless technique

Intervention Type PROCEDURE

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

tissue punching

Intervention Type PROCEDURE

just a punch of tissue taken to place dental implant

flap group

conventional flap elevation to place dental imp;lant

Group Type EXPERIMENTAL

flap technique

Intervention Type PROCEDURE

conventional flap elevation and drilling to place dental implant

Interventions

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flapless technique

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

Intervention Type PROCEDURE

flap technique

conventional flap elevation and drilling to place dental implant

Intervention Type PROCEDURE

tissue punching

just a punch of tissue taken to place dental implant

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patients that fulfill one or more of the following criteria were included:

1. Residual bone height of alveolar ridge more than 8 mm.
2. Residual bone width of alveolar ridge more than 4 mm.
3. Healthy and sufficient covering soft tissue (keratinized mucosa).
4. Distance between inferior border of mandible and the crest of alveolar ridge more than 2cm.
5. Motivated, cooperative patients with good oral hygiene.

Exclusion Criteria

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


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Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Abdalla Mohammed Faqe Wais

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marwa Taha Ibrahim, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

faculty of Dentistry, Tanta University, Egypt

Locations

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Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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OS 3-24-2165

Identifier Type: -

Identifier Source: org_study_id

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