NCT07171879

Brief Summary

This study is testing new methods to preserve the jawbone and gum tissue after removing a damaged front tooth. Normally, when a tooth is taken out, the bone and gums in that area shrink, which can make future dental treatment more difficult and affect appearance. A technique called Partial Extraction Therapy (Pontic Shield Technique) keeps part of the tooth root in place to help maintain the natural shape of the bone and gums. Another method, called Mineralized Plasmatic Matrix (MPM), uses a patient's own blood mixed with bone particles to support healing. In this randomized clinical trial, 56 patients were assigned to one of four groups: Group I: Tooth extraction only Group II: Tooth extraction with MPM grafting Group III: Pontic shield technique alone Group IV: Pontic shield technique with MPM grafting The main outcome measured was the amount of bone width preserved, using 3D X-rays (CBCT). Other outcomes included bone height and soft-tissue healing over 4 months. This research will help determine whether the pontic shield technique, with or without MPM, provides better preservation of bone and gum tissue compared to tooth extraction alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

September 6, 2025

Last Update Submit

September 11, 2025

Conditions

Keywords

Partial extraction therapyPontic shieldMineralized plasmatic matrix (MPM)Socket preservationWound healing index

Outcome Measures

Primary Outcomes (1)

  • Alveolar Ridge Width Change

    Mean changes in alveolar ridge width measured at standardized reference points on cone-beam computed tomography (CBCT) Unit of Measure: millimeters (mm)

    Baseline (pre- or immediate post-extraction) to 4 months.

Secondary Outcomes (2)

  • Buccal and Palatal Bone Height Change

    Baseline to 4 months.

  • Soft-Tissue Healing (Wound Healing Index, WHI)

    1 week and 4 months post-extraction.

Study Arms (4)

Extraction Only

ACTIVE COMPARATOR

Patients receive total tooth extraction in the esthetic maxillary zone without any adjunctive grafting.

Procedure: Tooth Extraction only

Extraction + MPM

ACTIVE COMPARATOR

Patients receive total tooth extraction in the esthetic maxillary zone, followed by grafting with MPM.

Procedure: Extraction + MPM

Pontic Shield Only

ACTIVE COMPARATOR

Patients undergo the pontic shield technique, in which a portion of the buccal root is preserved to maintain ridge contour, without grafting.

Procedure: Pontic Shield Only

Pontic Shield + MPM

ACTIVE COMPARATOR

Patients undergo the pontic shield technique combined with MPM grafting for ridge preservation.

Procedure: Pontic Shield + MPM

Interventions

Conventional atraumatic extraction of the non-restorable maxillary tooth in the esthetic zone without socket preservation procedures.

Extraction Only

Tooth extraction followed by socket grafting using MPM, prepared from autologous blood combined with xenograft bone particles.

Extraction + MPM

Partial extraction therapy using the pontic shield technique, in which the buccal root fragment is preserved to maintain ridge contour, without additional grafting.

Pontic Shield Only

Pontic shield technique combined with grafting using mineralized plasmatic matrix (MPM) for enhanced ridge preservation and healing.

Pontic Shield + MPM

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (≥18 years).
  • Classified as ASA I (healthy) according to the American Society of Anesthesiologists Physical Status Classification.
  • Presence of Type 1 extraction sockets (intact buccal bone and soft tissues).
  • Adequate oral hygiene.
  • Sufficient inter-arch space for prosthetic rehabilitation.
  • Willingness to comply with study protocol and follow-up schedule.

You may not qualify if:

  • Systemic conditions affecting bone metabolism or wound healing (e.g., uncontrolled diabetes, osteoporosis, immunosuppression).
  • History of head and neck radiotherapy or bisphosphonate therapy.
  • Acute infection or suppuration at the extraction site.
  • Severe periodontal disease.
  • Root caries or tooth mobility.
  • Buccal bone plate loss due to vertical/horizontal root fractures or advanced periodontitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Interventions

1-methyl-1-piperidinomethane sulfonate

Study Officials

  • Soaad Tolba Badawy, Lecturer, Oral Surgery, MU

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomized to one of four groups: extraction alone, extraction with MPM, pontic shield alone, or pontic shield with MPM.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University

Study Record Dates

First Submitted

September 6, 2025

First Posted

September 15, 2025

Study Start

September 1, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations