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Topical Dexamethasone, Ascorbic Acid, and BGP for Enhancing Implant Osseointegration (DAG)

M

Manar Ziad Foura-Matar

Status

Completed

Conditions

Implant Stability and Osseointegration

Treatments

Drug: Topical Application of Dexamethasone, Ascorbic Acid, and β-Sodium Glycerophosphate

Study type

Interventional

Funder types

Other

Identifiers

NCT07060859
DAG-RCT-2023

Details and patient eligibility

About

The goal of this clinical trial was to evaluate whether the topical application of a combination of dexamethasone, ascorbic acid, and β-sodium glycerophosphate could enhance implant osseointegration in adult dental implant patients. The main question it aimed to answer was:

Did the combined topical use of these agents improve implant stability during the healing phase?

Researchers compared intervention implants (which received the topical agents at the implant site) to control implants (which received standard placement without topical application) within the same participant, in order to assess differences in implant stability and osseointegration.

Participants:

Underwent dental implant surgery.

Received both the topical treatment and the standard procedure, applied to different implant sites.

Returned for follow-up visits, where implant stability was measured using resonance frequency analysis (RFA) at predefined time intervals.

Full description

This randomized clinical trial was conducted to investigate the effect of the topical application of a combination of dexamethasone, ascorbic acid, and β-sodium glycerophosphate on the osseointegration of dental implants. The rationale behind the study was based on existing evidence suggesting that these agents may enhance bone healing, reduce inflammation, and support mineralization when applied locally.

Each participant received two dental implants: one designated as the intervention site (treated with the topical combination of the three agents at the time of implant placement), and the other as the control site (placed without any topical application). This split-mouth design allowed intra-individual comparison, minimizing the influence of patient-related variability.

Implant stability was assessed using resonance frequency analysis (RFA) at four follow-up intervals to evaluate differences in osseointegration between the two sites. The study aimed to determine whether the adjunctive use of these agents could improve early implant stability, potentially contributing to more predictable outcomes in dental implantology.

No investigational drugs or devices were used beyond standard clinical tools. The study was approved by a local ethics committee, and informed consent was obtained from all participants prior to enrollment.

Enrollment

18 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Provided a written informed consent prior to initiation of any study procedures.
  2. Was able to understand and agrees to comply with planned study procedures and be available for all study visits.
  3. Agreed to undergo cone beam computed tomography (CBCT) imaging.
  4. Was a male or non-pregnant female, >/= to 18 years of age at the time of enrollment.
  5. Was in good general health, free medical diseases.
  6. Had two hopeless teeth for minimum required extraction for the purpose of implant-supported restorations.

Exclusion criteria

  1. Was undergoing chronic treatment with any medication known to affect oral status and bone turnover.
  2. Had a contraindication for surgical treatment.
  3. Was suffering from a known psychological disorder.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

18 participants in 2 patient groups

Intervention (Test)
Experimental group
Description:
Participants received a dental implant with the topical application of dexamethasone, ascorbic acid, and β-sodium glycerophosphate during surgery.
Treatment:
Drug: Topical Application of Dexamethasone, Ascorbic Acid, and β-Sodium Glycerophosphate
Control
No Intervention group
Description:
Participants received a dental implant using the standard surgical procedure without any topical application.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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