Tooth Extraction Status NosNCT05240417
"Pontic-shield" Technique in Alveolar Ridge Preservation
A study testing "Pontic-shield" technique and Alveolar ridge preservation in people with Tooth Extraction Status Nos and Bone Loss, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction Status Nos, Bone Loss, Bone Resorption
- What is being tested?
- "Pontic-shield" technique and Alveolar ridge preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2023to 1 Dec 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Luis Miguel Sáez-Alcaide
Madrid, 28011
Luis Miguel Sáez-Alcaide, PhD Student, +34665101278, lsaez@ucm.es
About this study
Official title: Effectiveness of "Pontic-shield" Technique in Alveolar Ridge Preservation: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Tooth Extraction Status Nos, Bone Loss, Bone Resorption
- Being tested
- "Pontic-shield" technique, Alveolar ridge preservation
- Keywords
- Tooth extraction, Alveolar ridge preservation, Partial extraction therapies, Bone resorption
- Medical subject headings
- Bone Diseases, Metabolic, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Pontic-shield" techniqueProcedure or surgery
Also called Partial extraction therapy
A 1mm thick fragment of the vestibular aspect of the root will remain after extraction (partial extraction)
Alveolar ridge preservationProcedure or surgery
Particulate deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | "Pontic-shield" will be performed as ridge preservation technique. Receives: Procedure: "Pontic-shield" technique |
| Positive control (ridge preservation) | Active comparator | Deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction. Receives: Procedure: Alveolar ridge preservation |
| Negative control (fresh socket) | No intervention | No intervention will be performed after tooth extraction. Blood clot will be maintained after extraction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the day of the extraction to 4 months after
Secondary outcomes (1)
Satisfaction assessed by visual analogue scale (VAS)
Postoperative pain with visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain)
Measured: From the day of the surgical procedure to the seventh-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Jan 2023
- Primary completion1 Nov 2023
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel three-arm randomized clinical study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesús Torres García Denche, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240417
- Sponsor's protocol ID
- 21/028-EC_X
- Status last verified
- Aug 2024
- First submitted
- 23 Jan 2022
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30623987Canullo 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.
PubMed 34826029Saez-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.
PubMed 34087383Hurzeler 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.
PubMed 20712701Araujo 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.
PubMed 15691354
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of "Pontic-shield" Technique in Alveolar Ridge Preservation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05240417
- Acronym / sponsor ID
- 21/028-EC_X
- Conditions
- Tooth Extraction Status Nos, Bone Loss, Bone Resorption
- Keywords
- Tooth extraction, Alveolar ridge preservation, Partial extraction therapies, Bone resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 15 Feb 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel three-arm randomized clinical study
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: "Pontic-shield" technique"Pontic-shield" will be performed as ridge preservation technique. |
| Positive control (ridge preservation) | Active comparator | Procedure: Alveolar ridge preservationDeproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction. |
| Negative control (fresh socket) | No intervention | –No intervention will be performed after tooth extraction. Blood clot will be maintained after extraction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| "Pontic-shield" techniqueAlso: Partial extraction therapyA 1mm thick fragment of the vestibular aspect of the root will remain after extraction (partial extraction) | Procedure or surgery | Study group |
| Alveolar ridge preservationParticulate deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction | Procedure or surgery | Positive control (ridge preservation) |
Primary outcome
Bone resorption
Time frame: From the day of the extraction to 4 months after
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.
1 secondary outcome
Satisfaction assessed by visual analogue scale (VAS)
Time frame: From the day of the surgical procedure to the seventh-day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 30623987Avila-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.
- Background: PubMed 34826029Canullo 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.
- Background: PubMed 34087383Saez-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.
- Background: PubMed 20712701Hurzeler 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.
- Background: PubMed 15691354Araujo 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.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Pontic-shield" technique and Alveolar ridge preservation in people with Tooth Extraction Status Nos and Bone Loss, run by Universidad Complutense de Madrid at 1 site in Spain.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Aug 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone resorption (time frame: From the day of the extraction to 4 months after). 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 NCT05240417, which also lists 5 linked publications.
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 20 Aug 2024.