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

NCT04296682 | Unknown

• 1 other identifier: 13838819.1.0000.5418
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alveolar Ridge Preservation; Connective Tissue

Outcome Measures

Primary Outcomes (1)

• Minor Alveolar dimensional loss with gingival graft.

  Horizontal and vertical bone loss measures after CBCT base and 3 months.

  3 months

Study Arms (2)

Atraumatic Extraction Without Gingival Graft

NO INTERVENTION

Alveolar closure with elevation of total flaps and simple suture (Silk thread 4.0, Ethicon, Johnson \& Johnson, SJC).

Atraumatic Extraction With Gingival Graft

EXPERIMENTAL

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

Interventions

Alveolar Ridge Preservation With Gingival Graft PROCEDURE

Closure of the alveolus with the placement of a free gingival tissue graft removed from the individual palate.

Atraumatic Extraction With Gingival Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

University of Campinas, UNICAMP

Piracicaba, São Paulo, 13414-903, Brazil

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Periodontics in Piracicaba Dental School-FOP/UNICAMP

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 5, 2020
• Study Start: January 20, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 21, 2020
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)