Impact Of Soft Tissue Manipulation On Dimensional Changes After Posterior Region Extraction.

Impact Of Soft Tissue Manipulation On Dimensional Changes After Posterior Region Extraction: A Randomized Controlled Trial

Alveolar preservation seek to avoid multiple surgical interventions to the patient and decrease costs to the patient. In particular, in a Brazilian population where the need for extraction is great, the development of techniques that safely allow a higher quality of rehabilitation is of paramount importance. Thus, this analysis is of great scientific and therapeutic importance. Within the above, the objective is to use an autogenous connective tissue graft in order to eliminate the need to raise the full-thickness flap and compensate for soft tissue deficiencies, which may reduce dimensional losses after extraction, in addition to reducing the cost of the technique.

Study Overview

• Status: Unknown
• Conditions: Alveolar Ridge Preservation; Connective Tissue
• Intervention / Treatment: Procedure: Alveolar Ridge Preservation With Gingival Graft

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Piracicaba, Sao Paulo, Brazil, 13414-903
      • Recruiting
      • University of Campinas, UNICAMP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Systemic health (absence of Hypertension and Diabetes);
• Indication of dental extraction of at least 2 teeth (with at least 2/3 of bone support, in the region of premolars or molars with indication for extraction;
• Signature of the consent form;
• Individuals over 18 years old.

Exclusion Criteria:

• Presence of periodontal disease at the time of surgery;
• Pregnant and lactating women;
• Smokers;
• Be under orthodontic treatment;
• Use medication that alters the bone healing process, such as those used to treat osteoporosis and the bisphosphonates group;
• Individuals under 18 years old.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Atraumatic Extraction Without Gingival Graft; Alveolar closure with elevation of total flaps and simple suture (Silk thread 4.0, Ethicon, Johnson & Johnson, SJC).
Experimental: Atraumatic Extraction With Gingival Graft; Closure of the alveolus without flap elevation, and placement of a free gingival tissue graft removed from the individual palate.	Procedure: Alveolar Ridge Preservation With Gingival Graft; Closure of the alveolus with the placement of a free gingival tissue graft removed from the individual palate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minor Alveolar dimensional loss with gingival graft.	Horizontal and vertical bone loss measures after CBCT base and 3 months.	3 months

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): December 21, 2020

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 13838819.1.0000.5418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No