Socket Preservation Using Socket-plug Technique With Alloplastic Putty Bone Versus Ice Cream Cone Technique in Extraction Socket With Buccal Dehiscence.

September 20, 2025 updated by: Abdelrahman Medhat, Cairo University

Socket Preservation Using Socket-plug Technique With Alloplastic Putty Bone Versus Ice Cream Cone Technique in Extraction Socket With Buccal Dehiscence: A Randomized Controlled Clinical Trial.

Socket Preservation Using Socket-plug Technique with Alloplastic Putty Bone Versus Ice Cream Cone Technique in Extraction Socket with Buccal Dehiscence: A Randomized Controlled Clinical Trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

this randomized controlled clinical trial evaluates the effect of using alloplastic putty bone with socket-plug technique versus ice-cream cone technique regarding dimensional changes in bone width

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Single or double rooted teeth indicated for extraction.
  • Systemically free patient
  • Presence of small buccal dehiscence not exceeding 1/3 of the root.
  • Maxillary and Mandibular Arches
  • Non-smoker
  • Adults or above the age of 21.
  • Able to tolerate surgical periodontal procedures.
  • Full mouth plaque and bleeding scores less than 15%.
  • Compliance with the maintenance program.
  • Provide informed consent

Exclusion Criteria:

  • Systemic conditions/disease that contraindicate surgical procedure.
  • Patients with presence or history of osteonecrosis of the jaws, with use of bisphosphonates, exposure to head and neck radiation, chemotherapy.
  • Extraction socket with intact walls with no buccal dehiscence
  • Patients with large distinct pre-apical pathology
  • Heavy Smokers more than 10 cigarettes a day
  • Patients without availability to attend follow-up visits or patients rejecting to sign the informed consent.
  • Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Socket-plug technique with putty bone
  • Patients will be anesthetized at the surgical site by infiltration, using Articaine Hydrochloride 4%.
  • Atraumatic extractions after careful surgical preparation of the soft and hard tissues using periotomes sulcular incision may be done with the aid of number 15c scalpel to dissect the crestal fibers and avoid trauma to soft tissue, care should be taken not to raise the flap.
  • Careful curettage and debridement of the socket is performed with hand instruments to remove granulation tissue.
  • The socket walls are then inspected for the presence of buccal defects.
  • putty bone is injected into the socket up to the crest of the bone.
  • Collagen plug or sponge is adapted over the graft to occlude the socket
  • The plug is then stabilized with absorbable suture material.
Procedure: socket-plug technique with putty bone
  • Atraumatic extractions after careful surgical preparation of the soft and hard tissues using periotomes sulcular incision may be done with the aid of number 15c scalpel to dissect the crestal fibers and avoid trauma to soft tissue, care should be taken not to raise the flap.
  • Careful curettage and debridement of the socket is performed with hand instruments to remove granulation tissue.
  • The socket walls are then inspected for the presence of buccal defects.
  • putty bone is injected into the socket up to the crest of the bone.
  • Collagen plug or sponge is adapted over the graft to occlude the socket
  • The plug is then stabilized with absorbable suture material.
Active Comparator: Ice cream cone technique
  • Patients will be anesthetized at the surgical site by infiltration, using Articaine Hydrochloride 4%.
  • Atraumatic extractions after careful surgical preparation of the soft and hard tissues using periotomes sulcular incision may be done with the aid of number 15c scalpel to dissect the crestal fibers and avoid trauma to soft tissue, care should be taken not to raise the flap.
  • Careful curettage and debridement of the socket is performed with hand instruments to remove granulation tissue.
  • The socket walls are then inspected for the presence of buccal defects.
  • A Collagen barrier membrane is then shaped as an ice-cream cone and placed in the extraction socket lining the buccal tissues.
  • The socket is then filled with particulate bone graft.
  • The upper part of the membrane is then used to cover the socket.
  • Absorbable suture is then used to close the socket and stabilize the barrier membrane
Procedure: Ice cream cone technique
  • Atraumatic extractions after careful surgical preparation of the soft and hard tissues using periotomes sulcular incision may be done with the aid of number 15c scalpel to dissect the crestal fibers and avoid trauma to soft tissue, care should be taken not to raise the flap.
  • Careful curettage and debridement of the socket is performed with hand instruments to remove granulation tissue.
  • The socket walls are then inspected for the presence of buccal defects.
  • A Collagen barrier membrane is then shaped as an ice-cream cone and placed in the extraction socket lining the buccal tissues.
  • The socket is then filled with particulate bone graft.
  • The upper part of the membrane is then used to cover the socket.
  • Absorbable suture is then used to close the socket and stabilize the barrier membrane

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quantitative volumetric changes
Time Frame: day 0 - month 6
Bone volumetric changes will be measured in millimeter by super-imposition of 3D scans using volume analysis software.
day 0 - month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Horizontal alveolar ridge width
Time Frame: day 0 - month 6
Buccolingual alveolar ridge width will be measured in millimeter 1, 3, 5 mm bellow alveolar crest in both groups.
day 0 - month 6
Vertical alveolar ridge height
Time Frame: day 0 - month 6
Vertical alveolar ridge height will be measured in millimeter from the end of the socket to the alveolar crest in both groups.
day 0 - month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 13, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PER6-3-1 ..

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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