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"Pontic-shield" Technique in Alveolar Ridge Preservation

Primary Purpose

Tooth Extraction Status Nos, Bone Loss, Bone Resorption

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
"Pontic-shield" technique
Alveolar ridge preservation
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Extraction Status Nos focused on measuring Tooth extraction, Alveolar ridge preservation, Partial extraction therapies, Bone resorption

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient from 18 to 80 years old
  • Patients who sign the informed consent
  • Need to perform extraction from second premolar to second premolar in maxilla and mandible

Exclusion Criteria:

  • Tobacco consumption (more than 10 cigarettes per day)
  • Severe systemic disease ( ASA III or IV - American Society of Anaesthesiology)
  • Drug use that could interfere with alveolar bone healing
  • Active periodontal disease
  • Acute or chronic apical pathology of the tooth

Sites / Locations

  • Luis Miguel Sáez-AlcaideRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Study group

Positive control (ridge preservation)

Negative control (fresh socket)

Arm Description

"Pontic-shield" will be performed as ridge preservation technique.

Deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction.

No intervention will be performed after tooth extraction. Blood clot will be maintained after extraction.

Outcomes

Primary Outcome Measures

Bone resorption
Radiographic changes between preoperative (prior to tooth extraction) and postoperative (4 months after intervention) will be analyzed. This variation will be assessed by measuring changes in width and height (in millimeters) of the socket by superimposition of CBCT before and after the intervention.

Secondary Outcome Measures

Satisfaction assessed by visual analogue scale (VAS)
Postoperative pain with visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain)

Full Information

First Posted
January 23, 2022
Last Updated
May 14, 2023
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT05240417
Brief Title
"Pontic-shield" Technique in Alveolar Ridge Preservation
Official Title
Effectiveness of "Pontic-shield" Technique in Alveolar Ridge Preservation: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Alveolar bone resorption after dental extraction frequently leads to situations in which long-term function and esthetic success of rehabilitations with dental implants is a challenge. "Pontic-shield" has been described as an alternative technique to maintain alveolar ridge after tooth extraction. The aim of this study is to analyze the effectiveness of "Pontic-shield" technique in alveolar ridge preservation comparing to fresh socket and ridge preservation using deproteinized bovine bone and a porcine collagen membrane.
Detailed Description
A three-arm randomized clinical study will be conducted: Group 1 (study group): Ridge preservation with "Pontic-shield" technique. Group 2 (positive control): Ridge preservation with deproteinized bovine bone and porcine collagen membrane after tooth extraction. Group 3 (negative control): Tooth extraction only (fresh socket). A cone-beam computed tomography will be performed prior to tooth extraction and 4 months postoperative. Radiographic changes between before and after intervention will be evaluated to asses the effectiveness of "Pontic-shield" technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Extraction Status Nos, Bone Loss, Bone Resorption
Keywords
Tooth extraction, Alveolar ridge preservation, Partial extraction therapies, Bone resorption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel three-arm randomized clinical study
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
"Pontic-shield" will be performed as ridge preservation technique.
Arm Title
Positive control (ridge preservation)
Arm Type
Active Comparator
Arm Description
Deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction.
Arm Title
Negative control (fresh socket)
Arm Type
No Intervention
Arm Description
No intervention will be performed after tooth extraction. Blood clot will be maintained after extraction.
Intervention Type
Procedure
Intervention Name(s)
"Pontic-shield" technique
Other Intervention Name(s)
Partial extraction therapy
Intervention Description
A 1mm thick fragment of the vestibular aspect of the root will remain after extraction (partial extraction)
Intervention Type
Procedure
Intervention Name(s)
Alveolar ridge preservation
Intervention Description
Particulate deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction
Primary Outcome Measure Information:
Title
Bone resorption
Description
Radiographic changes between preoperative (prior to tooth extraction) and postoperative (4 months after intervention) will be analyzed. This variation will be assessed by measuring changes in width and height (in millimeters) of the socket by superimposition of CBCT before and after the intervention.
Time Frame
From the day of the extraction to 4 months after
Secondary Outcome Measure Information:
Title
Satisfaction assessed by visual analogue scale (VAS)
Description
Postoperative pain with visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain)
Time Frame
From the day of the surgical procedure to the seventh-day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient from 18 to 80 years old Patients who sign the informed consent Need to perform extraction from second premolar to second premolar in maxilla and mandible Exclusion Criteria: Tobacco consumption (more than 10 cigarettes per day) Severe systemic disease ( ASA III or IV - American Society of Anaesthesiology) Drug use that could interfere with alveolar bone healing Active periodontal disease Acute or chronic apical pathology of the tooth
Facility Information:
Facility Name
Luis Miguel Sáez-Alcaide
City
Madrid
ZIP/Postal Code
28011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Miguel Sáez-Alcaide, PhD Student
Phone
+34665101278
Email
lsaez@ucm.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30623987
Citation
Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057. Erratum In: J Clin Periodontol. 2020 Jan;47(1):129.
Results Reference
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PubMed Identifier
34826029
Citation
Canullo L, Del Fabbro M, Khijmatgar S, Panda S, Ravida A, Tommasato G, Sculean A, Pesce P. Dimensional and histomorphometric evaluation of biomaterials used for alveolar ridge preservation: a systematic review and network meta-analysis. Clin Oral Investig. 2022 Jan;26(1):141-158. doi: 10.1007/s00784-021-04248-1. Epub 2021 Nov 26.
Results Reference
background
PubMed Identifier
34087383
Citation
Saez-Alcaide LM, Gonzalez Fernandez-Tresguerres F, Cortes-Breton Brinkmann J, Segura-Mori L, Iglesias-Velazquez O, Perez-Gonzalez F, Lopez-Pintor RM, Torres Garcia-Denche J. Socket shield technique: A systematic review of human studies. Ann Anat. 2021 Nov;238:151779. doi: 10.1016/j.aanat.2021.151779. Epub 2021 Jun 1.
Results Reference
background
PubMed Identifier
20712701
Citation
Hurzeler MB, Zuhr O, Schupbach P, Rebele SF, Emmanouilidis N, Fickl S. The socket-shield technique: a proof-of-principle report. J Clin Periodontol. 2010 Sep;37(9):855-62. doi: 10.1111/j.1600-051X.2010.01595.x.
Results Reference
background
PubMed Identifier
15691354
Citation
Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
Results Reference
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"Pontic-shield" Technique in Alveolar Ridge Preservation

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