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Treatment of NCCL Asociated With Gingival Recession With B.O.P.T. Technique

Primary Purpose

Abfraction

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Treatment of the abfraction with BOPT technique
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abfraction focused on measuring NCCL, B.O.P.T., Gingival recession

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Over 18 years of age, all sex; Presence of a non-carious lesion with loss of dental hard tissue, located in the cervical third of the tooth, and associated with R1 Cairo dental recession; as well, the tooth must be in a healthy condition. Exclusion Criteria: In the tooth to be treated: presence of tartar, periodontal pocket, gingival hypertrophy and/or dental mobility grades II and III; as well as presence of necrosis, fractures and prosthetic restorations; Presence of diabetes, coagulopathies, hemostatic and hormonal alterations, smoking habit of more than 10 cigarettes/day; Patients being treated with drugs whose side effects may cause gingival hypertrophy (eg hydantoins); Presence of any physical and/or mental condition that prevents voluntary giving informed consent to participate in the study.

Sites / Locations

  • Universidad de Valencia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cases

Arm Description

Patients belonging to the intervention group presented abfraction lesions in upper and/or lower premolars. These abfraction lesions consist of a loss of dental hard tissue at the cervical level of more than 1 mm, and are associated with type 1 gingival recession of the Cairo classification.

Outcomes

Primary Outcome Measures

On the tooth to be treated: Measurement of gingival recession associated to abfraction (before/after treatment).
The gingival recession associated with the abfraction lesion is digitally measured (in mm) through intraoral scanning of the same. Gingival recession is measured from the most coronal portion of the gingival margin to the cementoenamel junction at 3 fixed points (in mesial, medial, and distal). A software allows to overlay the initial scan with the post treatment scan; thus, the changes obtained thanks to the treatment in the height of the gingival margin are objectively measured.
On the tooth to be treated: Measurement of the volume of gingiva at the level of the gingival margin (before/after treatment).
The volume of the gingival tissue at the level of the margin, is measured through an initial intraoral scan, at 3 fixed points (the same points measured in the gingival recession, see outcome 1), from the outermost part of the gingiva to the outermost portion of the tooth root, seen in an occlusal view. A software allows to overlay the initial scan with the post treatment scan; thus, the volumetric changes obtained thanks to the treatment in the gingival margin are objectively measured.

Secondary Outcome Measures

Periodontal probing of all teeth
Value measured with a Williams periodontal probe with markings at 1-2-3-5-7-8-9-10 mm, from the bottom of the gingival sulcus to the gingival margin at 3 points (mesial, medial and distal).

Full Information

First Posted
February 28, 2023
Last Updated
May 12, 2023
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT05861193
Brief Title
Treatment of NCCL Asociated With Gingival Recession With B.O.P.T. Technique
Official Title
Treatment of NCCL Asociated With Gingival Recession With B.O.P.T. Technique
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
May 20, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Valencia

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
The purpose of this clinical trial is to evaluate the gingival margin changes resulting from the treatment with biologically oriented preparation technique (B.O.P.T.) of non-carious cervical lesions (NCCL). In particular, the quantification of the cervical margin is carried out by an intraoral scanning device, both in length and width.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abfraction
Keywords
NCCL, B.O.P.T., Gingival recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cases
Arm Type
Experimental
Arm Description
Patients belonging to the intervention group presented abfraction lesions in upper and/or lower premolars. These abfraction lesions consist of a loss of dental hard tissue at the cervical level of more than 1 mm, and are associated with type 1 gingival recession of the Cairo classification.
Intervention Type
Procedure
Intervention Name(s)
Treatment of the abfraction with BOPT technique
Intervention Description
The steps to follow for the treatment of abfraction using composite resin and the B.O.P.T. technique will consist of: Selection of the color of the composite, placement of the retraction cord and chamfering of the coronal margin of the lesion; Application of 37% phosphoric acid etching and adhesive in 3 steps; placement of the composite by layers, following the conventional obturation technique. Execution of an overfilling with the composite at the level of the cervical emergence profile of the tooth, with the aim of emphasizing said anatomical particularity. Removal of the retraction cord. Diamond milling with red rim flame diamond bur and contra-angle, positioned from the most apical point of the restoration at an angle of 45º without touching the restored dental portion, with the aim of performing a level rotary gingival curettage from the margin of the restoration. Polishing with a fine-grain flame bur, and polishing discs of decreasing granulometry.
Primary Outcome Measure Information:
Title
On the tooth to be treated: Measurement of gingival recession associated to abfraction (before/after treatment).
Description
The gingival recession associated with the abfraction lesion is digitally measured (in mm) through intraoral scanning of the same. Gingival recession is measured from the most coronal portion of the gingival margin to the cementoenamel junction at 3 fixed points (in mesial, medial, and distal). A software allows to overlay the initial scan with the post treatment scan; thus, the changes obtained thanks to the treatment in the height of the gingival margin are objectively measured.
Time Frame
The initial scan is performed prior to treatment, lasting approximately 5 minutes (maximum). The final scan is performed three month after treatment, once the gingival tissues have healed.
Title
On the tooth to be treated: Measurement of the volume of gingiva at the level of the gingival margin (before/after treatment).
Description
The volume of the gingival tissue at the level of the margin, is measured through an initial intraoral scan, at 3 fixed points (the same points measured in the gingival recession, see outcome 1), from the outermost part of the gingiva to the outermost portion of the tooth root, seen in an occlusal view. A software allows to overlay the initial scan with the post treatment scan; thus, the volumetric changes obtained thanks to the treatment in the gingival margin are objectively measured.
Time Frame
The initial scan is performed prior to treatment, lasting approximately 5 minutes (maximum). The final scan is performed three month after treatment, once the gingival tissues have healed.
Secondary Outcome Measure Information:
Title
Periodontal probing of all teeth
Description
Value measured with a Williams periodontal probe with markings at 1-2-3-5-7-8-9-10 mm, from the bottom of the gingival sulcus to the gingival margin at 3 points (mesial, medial and distal).
Time Frame
Before and after 3 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Over 18 years of age, all sex; Presence of a non-carious lesion with loss of dental hard tissue, located in the cervical third of the tooth, and associated with R1 Cairo dental recession; as well, the tooth must be in a healthy condition. Exclusion Criteria: In the tooth to be treated: presence of tartar, periodontal pocket, gingival hypertrophy and/or dental mobility grades II and III; as well as presence of necrosis, fractures and prosthetic restorations; Presence of diabetes, coagulopathies, hemostatic and hormonal alterations, smoking habit of more than 10 cigarettes/day; Patients being treated with drugs whose side effects may cause gingival hypertrophy (eg hydantoins); Presence of any physical and/or mental condition that prevents voluntary giving informed consent to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben Agustin Panadero, PDI-Titular
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Treatment of NCCL Asociated With Gingival Recession With B.O.P.T. Technique

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