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Dimensional Changes in Alveolar Ridge Preservation

Dimensional Changes After Different Alveolar Ridge Preservation Techniques for Posterior Region: Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06081296
Enrollment
80
Registered
2023-10-13
Start date
2022-09-01
Completion date
2024-09-01
Last updated
2023-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Loss

Brief 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.

Detailed 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.

Interventions

PROCEDUREControl group

Control Group (Ctl): alveolus closure with total flap elevation and simple suture; and socket sealing with mixed free gingival tissue graft.

PROCEDUREMixed 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.

PROCEDUREBone+ 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.

PROCEDUREBone + Titanium Seal group

socket closure without flap elevation, placement of lyophilized bone graft, socket sealing by installing a non-absorbable titanium membrane.

Sponsors

Renato Casarin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Randomization by electronically generated list; Different examiners than operator; Bliding patient;

Intervention model description

Randomized Clinical Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
assessment of dimensional change using linear measurements through CT, evaluating bone remodeling.6 monthsThrough CT taken immediately after tooth extraction and six months later, these images will be analyzed to evaluate changes in hard tissues

Secondary

MeasureTime frameDescription
evaluation of the dimensional change of soft tissues that accompany bone remodeling through linear and volume measurements in the STL6 monthsThrough STLs taken immediately after extraction and six months later, these images will be analyzed to evaluate changes in soft tissues
Visual analogy scale for pain and disconfort evaluattion which consists of a score to measure the patient's pain intensity.1 weekWill be also evaluate post-operative pain and discomfort,.

Countries

Brazil

Contacts

Primary ContactRenato Casarin, PhD
casarinrcv@yahoo.com+55 (19) 2106-5220
Backup ContactLeticia S Arroteia, DDS
leticia.sandoli@hotmail.com+55 (14) 981600821

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026