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Completed

NCT Number: NCT04403503

The Influence of Tissue Adhesive to Palatal Donor Site Healing.

CTG was harvested from 21 patients in each group. Donor site was treated with either GS (control) or GS+CY (test). Palatal tissue thickness, graft dimensions, working time (WT) and primary bleeding time were recorded intraoperatively. The data of pain perception (PP) will be measured using visual analog scale, quantity of analgesics (QA), secondary bleeding (SB), epithelization level (EL), and color match (CM) will be assessed prospectively. these outcomes will be evaluated in the first 7 days and 14th, 21th, and 28th days. Patient reported outcomes will be recorded using OHIB 14 questionnaire.

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Key information

Conditions

Donor Site Complication

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age ≥18;
  • PPS indication that needs CTG in anterior mandible;
  • stable periodontium after phase I therapy;
  • full-mouth plaque and bleeding scores <15%

Exclusion criteria

  • previous palatal harvesting history;
  • unstable endodontic conditions;
  • tooth mobility at surgical site;
  • systemic disease;
  • pregnancy;
  • use of medications with potential adverse effects to periodontal tissues

Treatment and study plan

Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]

Drug

Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group)

Cyanoacrylate, Isobutyl

Drug

Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group).

Primary outcomes

  1. Donor site pain perception (PP)

    Time frame: first week

    Patients score their daily donor site pain perception (PP) level by giving numbers from 0 to 10 according to the visual analog scale (VAS) (0: no pain, 1: minimal pain, 10: severe pain)

Secondary outcomes

  1. Primary bleeding time (PBT)

    Time frame: during surgery

    Immediately after harvesting, sterile gauze was compressed to the palatal wound for 2 minutes, blood wiped once in every 30 seconds until bleeding stops. The duration was recorded as primary bleeding time (PBT).

  2. Graft height (GH)

    Time frame: during surgery

    Dimensions were measured with periodontal probe

  3. Graft width (GW)

    Time frame: during surgery

    Dimensions were measured with periodontal probe

  4. Graft thickness (GT)

    Time frame: during surgery

    Dimensions were measured with periodontal probe

  5. Working time (WT)

    Time frame: during surgery

    Harvesting process was recorded

  6. Quantity of analgesics (QA)

    Time frame: first week

    Patients recorded the quantity of analgesics (QA) taken

  7. Secondary bleeding (SB)

    Time frame: first week

    Patients recorded presence/absence of secondary bleeding (SB) (yes or no).

  8. Sensation loss (SL)

    Time frame: first week, second week , third week, fourth week.

    Sensation loss (SL) was scored as none, medium or severe

  9. Color match (CM)

    Time frame: first week, second week, third week, fourth week.

    Color match (CM) with the adjacent tissue was determined by using a VAS scale (0: absence of harmony, 10: excellent harmony)

  10. Epithelization level (EL)

    Time frame: first week, second week, third week, fourth week.

    Epithelization level (EL) was scored as none, partial or full epithelization by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface following surgery

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

The Influence of Tissue Adhesive to Palatal Donor Site Healing. A Randomized Controlled Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 27, 2020
Registry last updated
Oct 2, 2024

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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