Clinical Evaluation of Biological Drilling Osteotomy Protocol Versus Conventional Drilling Osteotomy Protocol

NCT ID: NCT06992557

Last Updated: 2025-05-28

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-01-31

Brief Summary

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This study aims to evaluate the effect of biological drilling osteotomy protocol compared to conventional osteotomy protocol in delayed implant placement in the posterior mandible regarding implant stability Type of study design: Randomized Clinical Trial In patient indicated for delayed implant placement in the lower posterior mandible will the use of biological drilling protocol osteotomy compared to conventional drilling protocol osteotomy differ regarding implant stability at three months?

Detailed Description

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Conditions

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Implant Stability Low Speed Drilling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Biological drilling osteotomy protocol

* Local infiltration anesthesia will be applied to all the patients participating in this study.
* Full thickness mucoperiosteal flap reflection with 15c blade.
* Osteotomy site preparation through sequential biologic drilling in healed bony site with a pilot drill at 800 rpm with irrigation initiates the drilling process, which is then followed by drills of different sizes and shapes at low speeds at 150rpm without irrigation.
* The implant will be positioned in the osteotomy site and a healing collar will be placed.
* The mucoperiosteal flap will be sutured in an interrupted manner with 5-0 proline suture material

Group Type EXPERIMENTAL

Biological drilling osteotomy protocol

Intervention Type PROCEDURE

* Osteotomy site preparation through sequential biologic drilling in healed bony site with a pilot drill at 800 rpm with irrigation initiates the drilling process, which is then followed by drills of different sizes and shapes at low speeds at 150rpm without irrigation.
* The implant will be positioned in the osteotomy site and a healing collar will be placed.

Conventional drilling osteotomy protocol

* Local infiltration anesthesia will be applied to all the patients participating in this study.
* Full thickness mucoperiosteal flap reflection with 15c blade.
* Preparation for osteotomy site with conventional sequential drilling in healed bony site at 1200 rpm with irrigation.
* The implant will be positioned in the osteotomy site and a healing collar will be placed.
* The mucoperiosteal flap will be sutured in an interrupted manner with 5-0 proline suture material.

Group Type ACTIVE_COMPARATOR

Conventional drilling osteotomy protocol

Intervention Type PROCEDURE

* Preparation for osteotomy site with conventional sequential drilling in healed bony site at 1200 rpm with irrigation.
* The implant will be positioned in the osteotomy site and a healing collar will be placed.

Interventions

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Biological drilling osteotomy protocol

* Osteotomy site preparation through sequential biologic drilling in healed bony site with a pilot drill at 800 rpm with irrigation initiates the drilling process, which is then followed by drills of different sizes and shapes at low speeds at 150rpm without irrigation.
* The implant will be positioned in the osteotomy site and a healing collar will be placed.

Intervention Type PROCEDURE

Conventional drilling osteotomy protocol

* Preparation for osteotomy site with conventional sequential drilling in healed bony site at 1200 rpm with irrigation.
* The implant will be positioned in the osteotomy site and a healing collar will be placed.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Systemically healthy male and female patients, aged 21 to 60 years old,
* Indicated for delayed implant placement in the posterior mandibular arch.
* Good oral health.
* Willingness to sign the informed consent form.

Exclusion Criteria

* Heavy smoker (\> 10 cigarettes/day)
* Pregnant females
* Contraindication for Implant surgery.
* Patients with poor oral hygiene.
* A history of radiotherapy in the head or neck region.
* Patients with systemic disease like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation.
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mazen Mostafa Sayed

Assistant lecturer in The General Organization for Teaching Hospitals and Institutes

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo university , faculty of dentistry

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mazen Mostafa, master in periodontology

Role: CONTACT

00201005305913

Other Identifiers

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mazenmostafasayedali@@15121987

Identifier Type: -

Identifier Source: org_study_id

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