Flapless Versus Flap Technique for Evaluation of Crestal... | NCT07159529

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

NCT07159529

Sponsor

Tanta University

Status

Completed

Last Update Posted

Sep 8, 2025Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Posterior Mandible Missing Tooth and /or Teeth

Interventions

flapless technique
flap technique
tissue punching

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2024Actual

Primary Completion Date

Jan 31, 2025Actual

Completion Date

Feb 27, 2025Actual

First Submitted Date

Aug 29, 2025

First Submission Date that Met QC Criteria

Aug 29, 2025

First Posted Date

Sep 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2025

Last Update Posted Date

Sep 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
flapless group	Experimental	10 patients received dental implants just by taking a punch of tissue	Procedure: flapless technique Procedure: tissue punching
flap group	Experimental	conventional flap elevation to place dental imp;lant	Procedure: flap technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
flapless technique	Procedure	taking a punch of tissue to place dental implant through surgical guide	flapless group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion criteria:

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.

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marwa Taha Ibrahim, Assistant Professor	faculty of Dentistry, Tanta University, Egypt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry, Tanta University		Tanta	Gharbia Governorate	31527	Egypt

Intervention Model Description

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.