- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07171879
- Original Trial
Pontic Shield and Mineralized Plasmatic Matrix for Ridge Preservation (PONTIC-MPM)
Partial Extraction Therapy for Facial Contour Preservation, "Old is Gold or Time for Change?" A Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egypt, 35511
- Faculty of Dentistry, Mansoura University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Extraction Only
Patients receive total tooth extraction in the esthetic maxillary zone without any adjunctive grafting.
|
Conventional atraumatic extraction of the non-restorable maxillary tooth in the esthetic zone without socket preservation procedures.
|
|
Active Comparator: Extraction + MPM
Patients receive total tooth extraction in the esthetic maxillary zone, followed by grafting with MPM.
|
Tooth extraction followed by socket grafting using MPM, prepared from autologous blood combined with xenograft bone particles.
|
|
Active Comparator: Pontic Shield Only
Patients undergo the pontic shield technique, in which a portion of the buccal root is preserved to maintain ridge contour, without grafting.
|
Partial extraction therapy using the pontic shield technique, in which the buccal root fragment is preserved to maintain ridge contour, without additional grafting.
|
|
Active Comparator: Pontic Shield + MPM
Patients undergo the pontic shield technique combined with MPM grafting for ridge preservation.
|
Pontic shield technique combined with grafting using mineralized plasmatic matrix (MPM) for enhanced ridge preservation and healing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alveolar Ridge Width Change
Time Frame: Baseline (pre- or immediate post-extraction) to 4 months.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Buccal and Palatal Bone Height Change
Time Frame: Baseline to 4 months.
|
Change in buccal and palatal bone heights measured on CBCT from baseline to 4 months. Unit of Measure: mm |
Baseline to 4 months.
|
|
Soft-Tissue Healing (Wound Healing Index, WHI)
Time Frame: 1 week and 4 months post-extraction.
|
Clinical soft-tissue healing evaluated using the WHI.
Unit of Measure: score on 5-point scale with higher values indicating more favorable wound healing.
|
1 week and 4 months post-extraction.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Soaad Tolba Badawy, Lecturer, Oral Surgery, MU, Mansoura University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R.25.09.22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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