Ridge Preservation With Provisional Ovoid Pontic

Alveolar Process Atrophy Clinical Trial

Official title:

Ridge Preservation With Provisional Ovoid Pontic: a Randomized and Controlled Clinical-tomographic Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03166475
• Other study ID #: Reabilitação Oral
• Status: Completed
• Phase: N/A
• First received: May 22, 2017
• Last updated: May 23, 2017
• Start date: September 30, 2016
• Est. completion date: March 30, 2017

Study information

• Verified date: May 2017
• Source: Federal University of Juiz de Fora
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective randomized controlled trial of 30 patients from the Faculty of Dentistry of the UFJF was conducted. It was included patients who presented indication of extraction of premolars, canines or incisors. All the thirty patients underwent dental extraction and were randomly divided into three groups according to the study methodology. Plaster casts and Cone-Beam Computed Tomography (CBCT) exams were performed for comparative analysis between sample groups and between study times ( imediate postoperative and four months later).

Description:

Thirty consecutive patients who presented at the Dentistry College of Federal University of Juiz de Fora (Brazil) were selected, requiring a single-tooth extraction of premolar, canines or incisors in maxilla. All of the patients included at this study signed a free and informed consent form, agreeing to participate voluntarily in this research. The study was approved by the Research Ethical Committee of the University of Juiz de Fora under the form 1.731.395.

The patients were randomly allocated in three groups according the following treatments:

• Group 1: Closure of the socket by primary intention through a palatal pedicle subepithelial connective tissue flap by the technique of Khoury & Happe (2000) (Figure 1);

• Group 2: Filling the socket with a synthetic bone substitute of biphasic calcium phosphate (Bone Ceramic®, Straumann) and covering it with a palatal pedicle flap by the technique of Khoury & Happe (2000) (Figure 2);

• Group 3: Sealing of the socket with a provisional ovoid pontic of acrylic resin (Figure 3).

As response factors were performed evaluations of study casts and tomographic analysis for dimensional stability evaluation of the sockets at immediate postoperative and after four months of the surgical procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 30, 2017
• Est. primary completion date: January 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with indication of extraction of premolars, canines or incisors, which has two adjacent teeth, due to root fracture, extensive caries that did not allow unfavorable restorative and / or endodontic prognosis, systemically healthy.

Exclusion Criteria:

• Patients who use any drug that influences bone metabolism, patients with a history of head radiotherapy and neck, patients undergoing chemotherapy for the treatment of malignant tumors at the time of the study, patients with socket severely reabsorbed, smokers and pregnant women.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Alveolar Process Atrophy
• Atrophy

Intervention

Procedure:
• Surgical procedures
All the extractions were performed under local anaesthesia, minimally traumatic as possible. After the extraction, each patient was treated according to the group of their allocations.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Juiz de Fora

References & Publications (12)

Araújo MG, da Silva JC, de Mendonça AF, Lindhe J. Ridge alterations following grafting of fresh extraction sockets in man. A randomized clinical trial. Clin Oral Implants Res. 2015 Apr;26(4):407-12. doi: 10.1111/clr.12366. Epub 2014 Mar 12. — View Citation

Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Relationship between the buccal bone plate thickness and the healing of postextraction sockets with/without ridge preservation. Int J Periodontics Restorative Dent. 2014 Mar-Apr;34(2):211-7. doi: 10.1160 — View Citation

Fickl S, Fischer K, Petersen N, Happe A, Schlee M, Schlagenhauf U, Kebschull M. Dimensional Evaluation of Different Ridge Preservation Techniques: A Randomized Clinical Study. Int J Periodontics Restorative Dent. 2017 May/Jun;37(3):403-410. doi: 10.11607/ — View Citation

Iocca O, Farcomeni A, Pardiñas Lopez S, Talib HS. Alveolar ridge preservation after tooth extraction: a Bayesian Network meta-analysis of grafting materials efficacy on prevention of bone height and width reduction. J Clin Periodontol. 2017 Jan;44(1):104- — View Citation

Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hämmerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40 — View Citation

Khoury F, Happe A. The palatal subepithelial connective tissue flap method for soft tissue management to cover maxillary defects: a clinical report. Int J Oral Maxillofac Implants. 2000 May-Jun;15(3):415-8. — View Citation

Mardas N, Chadha V, Donos N. Alveolar ridge preservation with guided bone regeneration and a synthetic bone substitute or a bovine-derived xenograft: a randomized, controlled clinical trial. Clin Oral Implants Res. 2010 Jul;21(7):688-98. doi: 10.1111/j.16 — View Citation

Nart J, Barallat L, Jimenez D, Mestres J, Gómez A, Carrasco MA, Violant D, Ruíz-Magaz V. Radiographic and histological evaluation of deproteinized bovine bone mineral vs. deproteinized bovine bone mineral with 10% collagen in ridge preservation. A randomi — View Citation

Nevins M, Camelo M, De Paoli S, Friedland B, Schenk RK, Parma-Benfenati S, Simion M, Tinti C, Wagenberg B. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Int J Periodontics Restorative Dent. 2006 Feb;26(1):19-2 — View Citation

Ryu KH, Min S, You HK, Sin YW, Lee W, Lee J, Kiss A, Almohaimeed M, Zadeh HH. Alveolar ridge dimensional changes following ridge preservation procedure using SocketKAP(™) : exploratory study of serial cone-beam computed tomography and histologic analysis — View Citation

Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23. — View Citation

Ten Heggeler JM, Slot DE, Van der Weijden GA. Effect of socket preservation therapies following tooth extraction in non-molar regions in humans: a systematic review. Clin Oral Implants Res. 2011 Aug;22(8):779-88. doi: 10.1111/j.1600-0501.2010.02064.x. Epu — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of bone remodelation measured by Cone-Beam Computed Tomography exams and by plaster casts analysis, from baseline to 4 months	Will be measured width and height buccal-lingual of the ridge for each tooth extracted by the researcher.	Baseline (immediate postoperative) and 4 months after it.