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Bone Loss, Alveolar

A Randomized Control Trial Phase (IIIa) Unicentric, Placebo Controlled, Double-Blinded Efficacy and Safety of Topical Alendronic Acid on Alveolar Bone Remodeling After Tooth Extraction

Sponsored by Xeolas Pharmaceuticals Limited

About this trial

Last updated 2 years ago

Study ID

XeolasPharma

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18 to 90 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

The purpose of the study is to determine the efficacy and safety of the effects of a topical medication on bone remodeling after dental extraction, in order to establish whether such treatment can be a new therapeutic option for said pathology. The participation of 60 patients is expected, who will be divided randomly in equal proportions into two groups. Treatment groups: Group A (30 patients): medication administered topically. Group B (30 patients): placebo with characteristics equal to the drug under investigation.

What are the participation requirements?

Yes

Inclusion Criteria

- Provide signed and dated informed consent form.

- Overall, healthy patients that qualify for oral surgery (ASA I and II).

- Male and female patients 18-90 (inclusive) years of age.

- Requiring extraction of 1 tooth (maxillary or mandibular).

- Stable post-extraction socket walls with at least 4 walls.

- Adequate oral hygiene: plaque index < 25% before the surgery.

- Non-smoker or smoker of <10 cigarettes per day.

- Able to follow the instructions and able to meet the follow-ups.

- Healthy or controlled periodontal disease.

No

Exclusion Criteria

- Patients who do not agree with informed consent.

- Male and female patients are not 18-90 (inclusive) years of age. Patients taking medication that can interfere with the treatment such as Calcium Carbonate or Vitamin D.

- Untreated periodontal disease.

- Presence of dehiscence and/or fenestration at buccal plate of the extraction tooth/teeth.

- Patient who will need guided bone regeneration (GBR) or Block Regeneration after the extraction.

- History of head and/or neck radiation.

- History of chemotherapy in the five years prior of the surgery.

- Non controlled Diabetes.

- Chronic corticoids medication that may influence healing and/or osseointegration.

- Smoker of >10 cigars per day.

- Pregnant woman

- Alcohol or drugs.

- Patient going under bisphosphonates treatment or taking Denosumab (Prolia®).

- Patient with diagnosed osteoporosis, hypocalcemia, hypersensibility to alendronic acid or any of the excipients of Soludronate®.

Locations

Location

Status

Recruiting