Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06081296
Other study ID # 59208422.8.0000.5418
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date September 1, 2024

Study information

Verified date October 2023
Source University of Campinas, Brazil
Contact Renato Casarin, PhD
Phone +55 (19) 2106-5220
Email casarinrcv@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective: The objective is to evaluate the dimensional changes of soft tissue and alveolar ridge after extraction of posterior elements with different clinical protocols of alveolar preservation.


Description:

Detailed methodology: 80 individuals will be selected with need for extraction of premolar and molar elements, from both arches, for non-periodontal reasons, to participate in this randomized controlled clinical study. The dental elements will be extracted atraumatically, and allocated to one of the study groups (n=20/grp): Control Group (Ctl): alveolus closure with total flap elevation and simple suture; Group Free Gingival Mixed Graft (EGLM): closure of the alveolus without flap elevation, and placement of a mixed free gingival tissue graft (epithelialized in the central region and de-epithelialized (2 mm) in the vestibulolingual edges; Bone + Mixed Free Gum Graft Group (B+EGLM): socket closure without flap elevation, placement of lyophilized bone graft and socket sealing with mixed free gingival tissue graft (as previously described); Bone + Titanium Seal Group (B+TS): socket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane. Immediately after the extractions, Cone Beam Computed Tomography (90 kVp/8 mA/2.3 sec) will be performed, with lip/cheek separation, with 1.5 mm thick slices and a 1 mm distance, with a field of vision (FOV) of 5±5 cm, which will be repeated after 6 months. During the CT scans, the patients will use intra-oral appliances with hyperdense indicators to determine the reference points to measure the variables: bone tissue height in the center of the socket (primary variable) and every 2 mm equidistantly; thickness of bone tissue in the center of the socket and every 2 mm equidistantly. Soft tissue variables will also be evaluated, such as: mucosal thickness at the height and 2 mm below the edge margin (by CT); height of the keratinized tissue (measured by a dry tip caliper). After 6 months, all patients will receive dental implants, with the ideal measurements for bone dimension, and the possibility of installing implants >10mm or <10mm in length will be statistically analyzed. After 4 months of dental implant placement, single prostheses will be installed and CT, soft tissue measurements and clinical parameters will be repeated (peri-implant depth; presence of biofilm and bleeding on probing; tissue thickness at the margin and 2 mm below; keratinized tissue). Implants will be re-evaluated after 12 months. All measurements will be performed by a previously calibrated examiner (intra-class correlation above 90%). The data will initially be analyzed in a descriptive way, with means and standard deviations. For comparison between groups and times, two-way/Tukey ANOVA test will be used. In all analyses, a significance level of 5% will be considered.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date September 1, 2024
Est. primary completion date October 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Systemic health (Hypertension and Diabetes controlled) - Indication of tooth extraction with at least 2/3 of the bone support, in the premolar or molar region - Signing the consent form - Individuals over 18 years of age. Exclusion Criteria: - Presence of periodontal disease at the time of surgery - Pregnant and lactating women - Smokers - Being in orthodontic treatment - Use medication that alters the bone healing process, such as those used to treat osteoporosis and the bisphosphonate group - Individuals under 18 years of age

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Control group
Control Group (Ctl): alveolus closure with total flap elevation and simple suture; and socket sealing with mixed free gingival tissue graft.
Mixed free gingival graft group
closure of the alveolus without flap elevation, and placement of a free gingival tissue graft removed from the individual's own palate, which will be properly sutured. This graft is a combination of epithelialized-subepithelial connective tissue graft, which will be taken from the hard palate of the regions.
Bone+ mixed free gingival graft group
closure of the socket without flap elevation, placement of a freeze-dried bone graft and sealing of the socket with a mixed free gingival tissue graft.
Bone + Titanium Seal group
socket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane.

Locations

Country Name City State
Brazil Piracicaba Dental School Piracicaba São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Renato Casarin

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary assessment of dimensional change using linear measurements through CT, evaluating bone remodeling. Through CT taken immediately after tooth extraction and six months later, these images will be analyzed to evaluate changes in hard tissues 6 months
Secondary evaluation of the dimensional change of soft tissues that accompany bone remodeling through linear and volume measurements in the STL Through STLs taken immediately after extraction and six months later, these images will be analyzed to evaluate changes in soft tissues 6 months
Secondary Visual analogy scale for pain and disconfort evaluattion which consists of a score to measure the patient's pain intensity. Will be also evaluate post-operative pain and discomfort,. 1 week
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05470673 - Autogenous Demineralized Dentin Graft Combined With Injectable PRF + Metronidazole Versus Autogenous Demineralized Dentin Graft Alone for Alveolar Ridge Preservation N/A
Recruiting NCT02580721 - The Influence of Mucosal Tissue Thickness on Soft and Hard Tissue Changes Around Implants N/A
Completed NCT02515058 - Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts N/A
Enrolling by invitation NCT02209311 - Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tricalcium Phosphate and Autologous MMSCs Phase 1/Phase 2
Completed NCT02602223 - Comparison of Amnion Chorion Membrane vs. Dense Polytetrafluoroethylene Membrane in Ridge Preservation Procedures Phase 2
Completed NCT02255149 - A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw N/A
Recruiting NCT05674331 - Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Alveolar Ridge Preservation N/A
Completed NCT03944811 - Bone Height Gain Following Transcrestal Sinus Floor Elevation Using Piezoelectric Surgery Versus The Conventional Osteotome Technique N/A
Completed NCT03045458 - Associations of Alveolar Bone Loss and Interleukin-1β Levels in One and Two Stage Surgical Procedures N/A
Completed NCT05595746 - Radiological Bone Loss on Different Levels of Dental Implants N/A
Completed NCT03357705 - Effectiveness in Limiting the Need to Elevate the Maxillary Sinus N/A
Recruiting NCT05311735 - Mineralized and Partial Demineralized Dentin Graft Compared to FDBA N/A
Completed NCT05494476 - Stability of the Marginal Bone Around Subcrestal Implants N/A
Not yet recruiting NCT05536479 - Evaluation of Autogenous Stored Versus Autogenous Fresh Mineralized Dentin Graft for Alveolar Ridge Preservation N/A
Active, not recruiting NCT02275767 - Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft N/A
Active, not recruiting NCT02120053 - Interest of Bone Substitute Material in Immediate Complete Denture Phase 2/Phase 3
Completed NCT01728844 - GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery N/A
Terminated NCT00991432 - Localized Alveolar Ridge Augmentation With Space Maintenance Devices N/A
Terminated NCT00991965 - Localized Alveolar Ridge Augmentation With Dental Implant N/A
Completed NCT03149172 - Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials N/A