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Completed

NCT Number: NCT05850819

Effectiveness of Gelatamp in Wound Healing After Teeth Extraction: A Randomized Clinical Trial

This study compares the effectiveness of Gelatamp for intraoral wound closure after extraction of mandibular teeth.

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Key information

Conditions

Wound Heal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Melaka Manipal Medical College

Malacca, 75150, Malaysia

About this study

In the interventional group, after extraction of mandibular teeth, the extraction socket will be augmented with Gelatamp. Then a gauze pack will be placed over it.

In the control group, after extraction of mandibular teeth, a gauze pack will be placed over the socket.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients requiring extraction of mandibular teeth
  • Healthy patients (ASA I) or patients with mild systemic disease but no functional limitations (ASA II)
  • Patients not allergic to the drugs or anesthetics used in the study.

Exclusion criteria

  • Patients taking medications that influences wound healing
  • smokers
  • Uncooperative patients
  • Patients requiring extraction of grade II or III mobile teeth
  • Patients requiring surgical extraction of teeth.

Treatment and study plan

Colloidal silver gelatin sponge

Drug

Augment the extraction socket with Gelatamp

Other names: Gelatamp

Sterile gauze pack

Drug

Extraction socket allowed to heal without augmentation with any material

Primary outcomes

  1. Postoperative wound healing

    Time frame: 7th postoperative day

    A 5 point early wound healing scale assessing wound healing after 7 postoperative days

  2. Postoperative pain

    Time frame: 1st postoperative day

    A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).

  3. Postoperative pain

    Time frame: 2nd postoperative day

    A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).

  4. postoperative pain

    Time frame: 3rd postoperative day

    A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).

  5. postoperative pain

    Time frame: 4th postoperative day

    A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).

  6. postoperative pain

    Time frame: 5th postoperative day

    A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).

Secondary outcomes

  1. Presence of dry socket

    Time frame: 3rd postoperative day

    presence of pain, foul odour, exposed bone in the extraction socket

Sponsors and collaborators

Lead sponsor

Melaka Manipal Medical College

Other

Registry information

Official study title

Effectiveness of Gelatamp in Wound Healing After Extraction of Teeth: A Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 9, 2023
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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