NCT06655766

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

October 20, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

October 30, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

14 days

First QC Date

October 20, 2024

Last Update Submit

September 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quantitative volumetric changes

    Bone volumetric changes will be measured in millimeter by super-imposition of 3D scans using volume analysis software.

    day 0 - month 6

Secondary Outcomes (2)

  • Horizontal alveolar ridge width

    day 0 - month 6

  • Vertical alveolar ridge height

    day 0 - month 6

Study Arms (2)

Socket-plug technique with putty bone

EXPERIMENTAL

* 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

Ice cream cone technique

ACTIVE COMPARATOR

* 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

Interventions

* 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.

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. * 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

Ice cream cone technique

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant

Study Record Dates

First Submitted

October 20, 2024

First Posted

October 23, 2024

Study Start

October 30, 2025

Primary Completion

November 13, 2025

Study Completion

February 1, 2026

Last Updated

September 23, 2025

Record last verified: 2025-09