An interventional study of "Pontic-shield" technique and Alveolar ridge preservation in Tooth Extraction Status Nos, Bone Loss and Bone Resorption, sponsored by Universidad Complutense de Madrid. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
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.
A three-arm randomized clinical study will be conducted:
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.
661 studies on the registry are indexed under Bone Diseases, Metabolic; 93 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 509 interventional studies indexed under Bone Diseases, Metabolic.
Browse Bone Diseases, Metabolic studies →Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
"Pontic-shield" will be performed as ridge preservation technique.
Procedure: "Pontic-shield" technique
Deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction.
Procedure: Alveolar ridge preservation
No intervention will be performed after tooth extraction. Blood clot will be maintained after extraction.
A 1mm thick fragment of the vestibular aspect of the root will remain after extraction (partial extraction)
Also known as: Partial extraction therapy
Particulate deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction
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.
Time frame: From the day of the extraction to 4 months after
Satisfaction assessed by visual analogue scale (VAS)
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
Plan to share: No
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