Effectiveness of artificial materials in preserving bone and improving tooth retention - A comparative clinical study

Efficacy of biphasic synthetic calcium phosphate bone substitutes with different particle sizes in alveolar preservation for implant-supported dental restoration – A randomized, parallel-group clinical trial with a negative control

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-97qwcyb

Enrollment

336

Registered

2026-04-09

Start date

2026-04-13

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Bone Resorption Mouth Diseases

Interventions

This is a randomized, prospective, longitudinal, controlled clinical trial with parallel groups, conducted at a single center in the dental clinics of ATITUS Educação – Santa Terezinha Campus (Passo F

V1 (approx. 120 days after V0, with acceptable variation, for implant placement and temporary restoration when applicable)

V2 (approx. 120 days after V1, completion of prosthetic rehabilitation)

and late follow

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals aged 17 or older; both gender; capable of giving informed consent by signing an Informed Consent Form; in good general health; with clinical and radiographic indications for tooth extraction and the potential for subsequent implant-supported prosthetic rehabilitation; and using an appropriate method of contraception, when applicable

Exclusion criteria

Exclusion criteria: Individuals with local conditions that compromise surgery or healing; coagulation disorders; advanced periodontal disease; active infection at the surgical site; hypersensitivity to the study materials; systemic diseases that affect healing; use of illicit drugs; recent participation in other clinical trials; or pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
It is expected that the change in alveolar bone volume (?V), expressed in cubic millimeters (mm³), will be measured using Cone-Beam Computed Tomography (CBCT) at standardized time points throughout the study and compared to the baseline	—

Secondary

Measure	Time frame
An assessment of alveolar bone architecture is expected to be conducted through measurements of bone area, height, and width obtained from CT images, as well as participant-reported outcomes, including postoperative pain, assessed using a visual analog scale (VAS), and oral health-related quality of life, assessed using the Oral Health Impact Profile (OHIP-14) questionnaire. Additionally, procedure-related clinical complications, including edema and trismus, will be assessed using standardized methods at specific follow-up time points	—

Measure

Time frame

An assessment of alveolar bone architecture is expected to be conducted through measurements of bone area, height, and width obtained from CT images, as well as participant-reported outcomes, including postoperative pain, assessed using a visual analog scale (VAS), and oral health-related quality of life, assessed using the Oral Health Impact Profile (OHIP-14) questionnaire. Additionally, procedure-related clinical complications, including edema and trismus, will be assessed using standardized methods at specific follow-up time points

—

Countries

Contacts

Public ContactLeticia Patzlaff Bertolla

FGM Dental Group

leticia.bertolla@fgmdentalgroup.com+55 (47) 99203-8832

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: May 1, 2026