Tooth Extraction Status NosNCT02668289
Periodontal Phenotype Study (Tooth Extraction)
A study testing consent, Screening and Xray in people with Tooth Extraction Status Nos, run by Gustavo Avila-Ortiz DDS, MS, PhD at 1 site in United States.
Trial summary
The purpose of this trial is to determine the correlations between various tissue dimensions and the changes that occur following a single-tooth dental extraction in human adults. 65 adult subjects who are in need of dental extractions will be recruited. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction Status Nos
- What is being tested?
- consent, Screening and Xray
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2016to 15 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 to 75 years
- Gender: No restriction
- Subjects must require a single-rooted tooth extraction (Tooth deemed as periodontally and/or restoratively hopeless) in the maxillary anterior region (first premolar to first premolar)
- Subjects must be able and willing to follow instructions related to the study procedures
- Subjects must have read, understood and signed an informed consent form
Who cannot join
- More than 1 mm of recession present on the tooth planned for extraction and inclusion in the study
- Reported allergy or hypersensitivity to any of the products to be used in the study
- Severe hematologic disorders, such as hemophilia or leukemia
- Active severe infectious diseases that may compromise normal healing
- Liver or kidney dysfunction/failure
- Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy
Show all 15Show fewer
- Subjects who have a long-term history of oral bisphosphonate use (i.e. 10 years or more)
- Subjects with a history of IV bisphosphonates
- Subjects with uncontrolled diabetes, defined as Hba1c > 7.0
- Subjects with severe metabolic bone diseases, such as Paget's disease of bone, will be excluded
- Pregnant women or nursing mothers
- Heavy smokers: Subjects who have smoked >10 cigarettes per day within 6 months of study onset
- Concomitant medications: Subjects on concomitant drug therapy for systemic conditions that may affect the outcomes of the study will not be included in the study.
- NOTE: Occasional, short-term use (7-14 days) of analgesics or common cold medications is permitted. Use of such medications will be reviewed and recorded by the investigator.
- Any other non-specified reason that from the point of views of the investigators will make a candidate not a suitable subject for the study (e.g. limited mouth opening).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periodontal Phenotype and Supracrestal Soft Tissue Dimentions - Clinical Correlations and Their Impact on Post-extraction Volumetric Changes
The purpose of this trial is to determine the correlations between various tissue dimensions and the changes that occur following a single-tooth dental extraction in human adults.
65 adult subjects who are in need of dental extractions will be recruited. Clinical measurements will be gathered prior to and immediately following the single tooth extraction. There will be a 2-week post-operative visit to assess healing and a 14-week follow-up for photographic documentation and clinical measurements of the extraction area.
Read the detailed description
Periodontal phenotype, also known as periodontal biotype, has been recognized as one of the key factors that may potentially impact the outcome of a variety of esthetic restorative procedures. With the increasing esthetic demand of patients in the context of tooth replacement therapy in the anterior esthetic zone, the ability to determine the prognostic value and the influence on treatment outcomes of this parameter has become a critical component of contemporary treatment planning. Periodontal phenotype encompases "bone morphotypes, shapes of the teeth, morphologic characteristics of the gingiva and the periodontium".
- Conditions
- Tooth Extraction Status Nos
- Being tested
- consent, Screening, Xray, PVS Impressions, Photographs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
consentOther
At the initial screening examination, each subject will receive an informed consent form. Prior to signing the informed consent, one of the investigators or qualified staff will thoroughly discuss participation in the study with each subject, allocating time for questions and answers.
ScreeningOther
At the initial screening examination, complete medical and dental history will be obtained to verify eligibility.
XrayOther
each subject will undergo site-specific oral radiographic exam (new periapical radiographs will be obtained if needed) to evaluate potential study sites.
PVS ImpressionsOther
PVS impressions of the arch of interest will be obtained in order perform volumetric analysis of the area of interest.
PhotographsOther
Intraoral photographs will also be taken and subsequent study visits will be planned.
CBCTOther
The patient will then be sent to the Department of Radiology at the College of Dentistry for a baseline CBCT and follow-up at 14 week CBCT. These CBCT's will be utilized to evaluate the hard tissue volume in comparison to the clinical volume of soft tissue.
AnesthesiaOther
After appropriate local anesthetic is administered and anesthesia is achieved, the buccal tissue thickness will be measured and recorded.
ExtractionProcedure or surgery
After the pre-extraction baseline measurements are recorded and adequate anesthesia is confirmed, minimally invasive extraction procedures will be initiated. All extractions will be performed by residents in the UI CoD Periodontics advanced education program.
Clinical measurementsOther
Measuring soft tissue dimensions, bone thickness prior to and immediately after extraction and then after appropriate healing time frames.
| Study group | Role | What they receive |
|---|---|---|
| interventional | Other | consent, screening, xrays, PVS impressions, photographs, CBCT, anesthesia, extraction, clinical measurements Receives: Other: consent; Other: Screening; Other: Xray; Other: PVS Impressions; Other: Photographs; Other: CBCT; Other: Anesthesia; Procedure: Extraction; Other: Clinical measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in tissue volume - Rank Correlations
For the purpose of this study, a 10-20% reduction in the volume must detectable. Pearson correlations will be used to assess associations if appropriate and Spearman rank correlations will be considered if needed.
Measured: 14 weeks
Secondary outcomes (3)
Probing Depths of soft tissue dimensions
supracrestal soft tissue dimensions will be evaluated
Measured: 14 weeks
bone thickness ( facial and lingual) - Correlations
Analogous correlational approaches, supplemented by regression methods, will be used to assess the relationships between measurements made by CBCT with those derived from volumetric analysis of casts.
Measured: 14 weeks
soft tissue thickness (facial and lingual) -correlations
correlations among the periodontal phenotype and the supracrestal soft tissue dimensions will be evaluated.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start31 Jan 2016
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth Extraction Status NosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustavo Avila-Ortiz DDS, MS, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gustavo Avila-Ortiz DDS, MS, PhD, University of Iowa
- Investigators
- Gustavo Avila Ortiz, BSE, DDS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668289
- Sponsor's protocol ID
- 201510790
- Status last verified
- Nov 2022
- First submitted
- 26 Jan 2016
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Couso-Queiruga E, Graham ZA, Peter T, Gonzalez-Martin O, Galindo-Moreno P, Avila-Ortiz G. Effect of periodontal phenotype characteristics on post-extraction dimensional changes of the alveolar ridge: A prospective case series. J Clin Periodontol. 2023 May;50(5):694-706. doi: 10.1111/jcpe.13781. Epub 2023 Feb 1.
PubMed 36644815
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Phenotype and Supracrestal Soft Tissue Dimentions - Clinical Correlations and Their Impact on Post-extraction Volumetric Changes
- ClinicalTrials.gov ID
- NCT02668289
- Acronym / sponsor ID
- 201510790
- Conditions
- Tooth Extraction Status Nos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Gustavo Avila-Ortiz DDS, MS, PhDUniversity, hospital or other
- Study start
- 31 Jan 2016 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to determine the correlations between various tissue dimensions and the changes that occur following a single-tooth dental extraction in human adults.
65 adult subjects who are in need of dental extractions will be recruited. Clinical measurements will be gathered prior to and immediately following the single tooth extraction. There will be a 2-week post-operative visit to assess healing and a 14-week follow-up for photographic documentation and clinical measurements of the extraction area.
Detailed description
Periodontal phenotype, also known as periodontal biotype, has been recognized as one of the key factors that may potentially impact the outcome of a variety of esthetic restorative procedures. With the increasing esthetic demand of patients in the context of tooth replacement therapy in the anterior esthetic zone, the ability to determine the prognostic value and the influence on treatment outcomes of this parameter has become a critical component of contemporary treatment planning. Periodontal phenotype encompases "bone morphotypes, shapes of the teeth, morphologic characteristics of the gingiva and the periodontium".
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interventional | Other | Other: consent, Other: Screening, Other: Xray, Other: PVS Impressions, Other: Photographs, Other: CBCT, Other: Anesthesia, Procedure: Extraction, Other: Clinical measurementsconsent, screening, xrays, PVS impressions, photographs, CBCT, anesthesia, extraction, clinical measurements |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 to 75 years
- Gender: No restriction
- Subjects must require a single-rooted tooth extraction (Tooth deemed as periodontally and/or restoratively hopeless) in the maxillary anterior region (first premolar to first premolar)
- Subjects must be able and willing to follow instructions related to the study procedures
- Subjects must have read, understood and signed an informed consent form
Key exclusion criteria (15 listed)
- More than 1 mm of recession present on the tooth planned for extraction and inclusion in the study
- Reported allergy or hypersensitivity to any of the products to be used in the study
- Severe hematologic disorders, such as hemophilia or leukemia
- Active severe infectious diseases that may compromise normal healing
- Liver or kidney dysfunction/failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| consentAt the initial screening examination, each subject will receive an informed consent form. Prior to signing the informed consent, one of the investigators or qualified staff will thoroughly discuss participation in the study with each subject, allocating time for questions and answers. | Other | interventional |
| ScreeningAt the initial screening examination, complete medical and dental history will be obtained to verify eligibility. | Other | interventional |
| Xrayeach subject will undergo site-specific oral radiographic exam (new periapical radiographs will be obtained if needed) to evaluate potential study sites. | Other | interventional |
| PVS ImpressionsPVS impressions of the arch of interest will be obtained in order perform volumetric analysis of the area of interest. | Other | interventional |
| PhotographsIntraoral photographs will also be taken and subsequent study visits will be planned. | Other | interventional |
| CBCTThe patient will then be sent to the Department of Radiology at the College of Dentistry for a baseline CBCT and follow-up at 14 week CBCT. These CBCT's will be utilized to evaluate the hard tissue volume in comparison to the clinical volume of soft tissue. | Other | interventional |
| AnesthesiaAfter appropriate local anesthetic is administered and anesthesia is achieved, the buccal tissue thickness will be measured and recorded. | Other | interventional |
| ExtractionAfter the pre-extraction baseline measurements are recorded and adequate anesthesia is confirmed, minimally invasive extraction procedures will be initiated. All extractions will be performed by residents in the UI CoD Periodontics advanced education program. | Procedure or surgery | interventional |
| Clinical measurementsMeasuring soft tissue dimensions, bone thickness prior to and immediately after extraction and then after appropriate healing time frames. | Other | interventional |
Primary outcome
Percentage change in tissue volume - Rank Correlations
Time frame: 14 weeks
For the purpose of this study, a 10-20% reduction in the volume must detectable. Pearson correlations will be used to assess associations if appropriate and Spearman rank correlations will be considered if needed.
3 secondary outcomes
Probing Depths of soft tissue dimensions
Time frame: 14 weeks
bone thickness ( facial and lingual) - Correlations
Time frame: 14 weeks
soft tissue thickness (facial and lingual) -correlations
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Derived from this study: PubMed 36644815Couso-Queiruga E, Graham ZA, Peter T, Gonzalez-Martin O, Galindo-Moreno P, Avila-Ortiz G. Effect of periodontal phenotype characteristics on post-extraction dimensional changes of the alveolar ridge: A prospective case series. J Clin Periodontol. 2023 May;50(5):694-706. doi: 10.1111/jcpe.13781. Epub 2023 Feb 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustavo Avila Ortiz, BSE, DDS principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing consent, Screening and Xray in people with Tooth Extraction Status Nos, run by Gustavo Avila-Ortiz DDS, MS, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in tissue volume - Rank Correlations (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02668289, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022; AzTrials last refreshed its copy on 27 Oct 2026.