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Pain and clinical characteristics following Crown Lengthening: study in smokers and non-smokers

Pain management and clinical characteristics after Gingival Surgery in smokers and non-smokers: randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-8rvtccf
Enrollment
Unknown
Registered
2024-01-05
Start date
2024-02-01
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

Tobacco Use Disorder

Interventions

In this study, crown lengthening surgeries will be performed on both smokers and non-smokers. The aim is to assess the effectiveness of two post-operative pain management protocols and the healing of

Sponsors

Universidade Federal de Pelotas
Lead Sponsor
Universidade Federal de Pelotas
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Men and women aged at least 18 years; available to participate in all study phases; with a diagnosis of periodontal health in either intact or reduced periodontium; requiring ACC periodontal surgery with a need for osteotomy of at least 1 mm to restore supracrestal structures (periapical radiographs and/or transperiodontal probing will be used to determine the need for osteotomy in these patients); in the non-smoker group, only individuals who report never having smoked or having quit smoking for more than five years will be included; in the smoker group, only individuals who report daily consumption of at least ten cigarettes will be included

Exclusion criteria

Exclusion criteria: Individuals requiring crown lengthening for purely aesthetic purposes; those using any type of orthodontic appliance; individuals with soft or hard tissue tumors in the oral cavity; presence of active infectious foci (endodontic abscesses); chronic use of analgesics or anti-inflammatories for any condition, or use of any analgesics, anti-inflammatories, or chlorhexidine mouthwashes in the seven days preceding the periodontal surgery; this also includes pregnant or lactating; those who have received local or systemic antimicrobial treatment in the last 90 days; individuals requiring antimicrobial prophylaxis for dental treatment; individuals with a history of allergy to paracetamol, ibuprofen, or dipyrone, including their byproducts; a history of allergy to chlorhexidine, including its byproducts; patients with uncontrolled systemic diseases (such as diabetes); patients on anticoagulants or platelet anti-aggregants

Design outcomes

Primary

MeasureTime frame
To evaluate postoperative pain after clinical crown augmentation, using the Visual Analogue Scale. We will observe the mean and standard deviation of postoperative pain after 1h, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 5 and 7 days after surgery.

Secondary

MeasureTime frame
To evaluate periodontal healing after clinical crown augmentation, verified by the Healing Indices proposed by Landry et al. (1988) and Gingival Healing Index (GCI), proposed by Trombelli et al. (2018). We will observe the mean and standard deviation of periodontal healing scores, for each index, after 7, 14 and 28 days after surgery.;To evaluate preoperative anxiety, verified using the scale proposed by Corah and validated in Brazil by Li Wen Hu. We will observe the mean and standard deviation of preoperative anxiety only in the period before surgery.;Evaluate postoperative recovery, verified using the QoR-40 scale. We will observe the mean and standard deviation of postoperative recovery after 7, 14 and 28 days after surgery.;Assess periodontal health, being verified by the clinical visible plaque index. We will observe the mean and standard deviation of this postoperative index 7, 14 and 28 days after surgery.;Assess periodontal health, being checked by the marginal bleeding index. We will observe the mean and standard deviation of this postoperative index 7, 14 and 28 days after surgery.;Assess periodontal health, being checked for the presence of plaque retention factors. We will observe the mean and standard deviation of this postoperative index 7, 14 and 28 days after surgery.;Assess periodontal health, being verified by loss of attachment. We will observe the mean and standard deviation of this postoperative index 28 days after surgery.;Assess periodontal health, being checked by bleeding on probing. We will observe the mean and standard deviation of this postoperative index 28 days after surgery.

Countries

Brazil

Contacts

Public ContactFrancisco Wilker Muniz

Universidade Federal de Pelotas

wilkermustafa@gmail.com+55(53)3222-2766

Outcome results

None listed

Source: REBEC (via WHO ICTRP)