Effectiveness of using a Customizable Healing Device for dental Implants: a Clinical Trial

Effectiveness of using a Customizable Healing Device for Immediate Implants in the posterior region: a Randomized Clinical Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-38c5f2h

Enrollment

Unknown

Registered

2024-04-17

Start date

2021-05-14

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

gingiva

Interventions

This is a randomized experimental clinical study that will evaluate postoperative pain and tissue behavior in the posterior area of the maxilla and/or mandible, in patients undergoing tooth extraction

In the control, Lumina PTFE non-resorbable barrier/membrane and suture will be used as a way to buffer the surgical procedure. There will be two consultations required for the research: the first for

E06.780.346.706

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Being indicated and extraction of posterior teeth and installation of dental implants; participants agree and sign the consent form; being in satisfactory health conditions to undergo treatment

Exclusion criteria

Exclusion criteria: Participants do not agree or do not sign the consent form; not being in systemic health conditions to carry out the treatment; failure to meet technical conditions for immediate dental implant installation after extraction. Teeth with furcation lesion or loss of gingival papillae will be excluded from the research

Design outcomes

Primary

Measure	Time frame
Expected outcome: The customizable healing abutment is expected to better maintain the gingival papilla, preserve a larger volume of ridge, and sustain a greater thickness of keratinized tissue band compared to conventional treatment (PTFE barrier). Postoperative pain will not be influenced by the use of a customizable healing abutment, compared to conventional treatment;Outcome found: Taking into consideration all the characteristics evaluated by the study, the outcome "papilla alteration" was the one that resulted in statistical difference, with the control group showing higher values of difference between papilla before and after than the experimental group. For the other characteristics, there was no statistical difference between the groups	—

Measure

Time frame

Expected outcome: The customizable healing abutment is expected to better maintain the gingival papilla, preserve a larger volume of ridge, and sustain a greater thickness of keratinized tissue band compared to conventional treatment (PTFE barrier). Postoperative pain will not be influenced by the use of a customizable healing abutment, compared to conventional treatment;Outcome found: Taking into consideration all the characteristics evaluated by the study, the outcome "papilla alteration" was the one that resulted in statistical difference, with the control group showing higher values of difference between papilla before and after than the experimental group. For the other characteristics, there was no statistical difference between the groups

—

Secondary

Measure	Time frame
No secondary outcomes were expected	—

Countries

Brazil

Contacts

Public ContactPedro Corazza

Fundação Universidade de Passo Fundo

pedrocorazza@yahoo.com.br+55 (54) 3316-8395

Outcome results

None listed

Source: REBEC (via WHO ICTRP)